Back to resultsA Cohort Study of Non-surgical Treatment and Exercise Rehabilitation in Patients With Anterior Cruciate Ligament Rupture
Primary Purpose
Anterior Cruciate Ligament Rupture, Osteoarthritis, Knee
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
non surgical treatment
surgical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Rupture focused on measuring Anterior cruciate ligament (ACL), OA, non-surgical treatment, rehabilitation
Eligibility Criteria
Inclusion Criteria:
1) Age 8-45 years old 2) Complete rupture of unilateral anterior cruciate ligament (ACL) (with/without partial meniscus tear) 3) The history of ACL injury should not be more than 2 months before enrollment 4) Complete rupture of the ACL as determined by clinical examination and MRI 5) Activity level scale 5-9 (Tegner activity score) 6) Degeneration of knee joint <KL II degree, intraoperative cartilage injury < ICRS III degree.
7) The reason for the rupture of the anterior cruciate ligament is sports trauma.
8) Complete rupture of the ACL meets the MRI indications: (1) The signal changes, deforms, and thickens on imaging, and is completely broken but not separated; (2) There is no sagging and separation of the broken ends; (3) The synovial image is continuous.
9) The physical examination of complete ACL rupture meets the following indications: (1) Lachman (-) or ADT (-) has one of them; (2) or both are slightly loose, and the slack is not more than 10mm; (3) vertical Leg position ADT (-) or slack <5mm.
Exclusion Criteria:
- 1) Used in the previous 12 months 1. Intra-articular injection 2. Physical therapy 2) Those who broke again after surgery and underwent knee surgery in other hospitals 3) Previous knee surgery (except diagnostic arthroscopy) 4) Active infection of the knee joint within the past 12 months 5) Informed consent cannot be given 6) History of knee gout 7) Include one or more of the following knee-related injuries: 8) Unstable meniscus tears requiring repair or post-operative changes in rehabilitation Bicompartmental wide meniscectomy Total collateral ligament rupture full thickness cartilage lesions 9) History of rheumatoid arthritis or similar rheumatic diseases 10) The discovery of rheumatoid arthritis, rheumatoid arthritis pigment villonodular synovitis and other joint diseases during the postoperative follow-up period may impair the ability to participate in the study 11) Unable to speak/understand the research content, lack of autonomy, unable to walk, or unable to participate in follow-up 12) Participate in any drug trials during and after the disease 13) Any other medical condition that considers the longest survival time to be less than 2 years 14) Immunodeficiency or HIV positive 15) Illegal drug use or chronic alcoholism or total daily alcohol intake > 50 g/d 16) Pregnancy/planning pregnancy 17) There are contraindications such as current or previous history of neurological disease, cerebrovascular and serious cardiovascular disease, including coronary heart disease (angina pectoris, myocardial infarction, coronary angiogenesis process or abnormal electrocardiogram Q wave appearance (ECG)), Stroke (ischemic or hemorrhagic, including transient ischemic attack), peripheral arterial disease diagnosed by angiography 18) No imaging diagnosis 19) History of deep vein thrombosis (DVT) or blood system 20) There is a systemic disease that affects physical function, or there is any other condition or treatment that prevents the completion of the trial, including patients with metal devices or movement disorders
Sites / Locations
- Institute of Sports Medicine, Peking University Third HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
non-surgical treatment
surgical treatment
Arm Description
The patient who was diagnosed with complete rupture of the ACL in the Institute of Sports Medicine of the Third Hospital of Peking University was informed by the doctor that there is a chance that the ACL may grow back after 6 weeks of strict bracing.
The patient who was diagnosed with complete rupture of the ACL in the Institute of Sports Medicine of the Third Hospital of Peking University was informed by the doctor that there is a chance that after 6 weeks of strict brace immobilization, the ACL may grow back without surgery. However, the choice was still made for immediate ACL reconstruction. This group of patients underwent anterior cruciate ligament reconstruction surgery in the Third Hospital of Peking University.
Outcomes
Primary Outcome Measures
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.The role of IKDC2000 is not only to compare the prognosis of the knee joint between the surgical group and the non-surgical group, but also to the normal population we mentioned in the article according to The International Knee Documentation Committee Subjective Knee Evaluation Form Normative Data Allen F. Anderson,*† AJSM The IKDC2000 values of different genders and ages were used to judge whether the two groups of patients reached the standard of normal people after surgery.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.The role of IKDC2000 is not only to compare the prognosis of the knee joint between the surgical group and the non-surgical group, but also to the normal population we mentioned in the article according to The International Knee Documentation Committee Subjective Knee Evaluation Form Normative Data Allen F. Anderson,*† AJSM The IKDC2000 values of different genders and ages were used to judge whether the two groups of patients reached the standard of normal people after surgery.
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.The role of IKDC2000 is not only to compare the prognosis of the knee joint between the surgical group and the non-surgical group, but also to the normal population we mentioned in the article according to The International Knee Documentation Committee Subjective Knee Evaluation Form Normative Data Allen F. Anderson,*† AJSM The IKDC2000 values of different genders and ages were used to judge whether the two groups of patients reached the standard of normal people after surgery.
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Knee laxity （physical exam）
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Knee laxity （KT-2000 arthrometer）
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Magnetic resonance imaging (MRI)
Magnetic resonance imaging was used to compare lateral comparisons of ligament healing and ACL graft healing after conservative treatment, meniscal damage and knee cartilage damage after intervention.
Secondary Outcome Measures
Gender
Measuring whether gender is a risk factor for anterior cruciate ligament reconstruction failure.
Age
Measuring whether age is a risk factor for anterior cruciate ligament reconstruction failure
BMI
Weight and height will be combined to report BMI in kg/m^2. Measuring whether bmi is a risk factor for anterior cruciate ligament reconstruction failure
Single-Legged Hop Test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Single-Legged Hop Test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Single-Legged Hop Test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Triple hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Triple hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Triple hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Cross hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Cross hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Cross hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
6-m hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
6-m hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
6-m hop test
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Knee laxity
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Knee laxity
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Quadriceps strength
Side to side quadriceps strength assessed by Biodex arthrometer test
Lysholm score
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Lysholm score
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Lysholm score
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Tegner Score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Tegner Score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Tegner Score
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
hort Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)
Patients will be asked to fill out the SF-36 to document the quality of life . General health-related quality of life: SF-36 physical component score (range 0 to 100; higher score = better health state) at 2 yearsTh minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Magnetic resonance imaging (MRI)
Magnetic resonance imaging was used to compare lateral comparisons of ligament healing and ACL graft healing after conservative treatment, meniscal damage and knee cartilage damage after intervention.
Magnetic resonance imaging (MRI)
Magnetic resonance imaging was used to compare lateral comparisons of ligament healing and ACL graft healing after conservative treatment, meniscal damage and knee cartilage damage after intervention.
Knee laxity （KT-2000 arthrometer）
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Knee laxity （KT-2000 arthrometer）
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Full Information
NCT ID
NCT05403905
First Posted
May 31, 2022
Last Updated
May 31, 2022
Sponsor
Peking University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05403905
Brief Title
A Cohort Study of Non-surgical Treatment and Exercise Rehabilitation in Patients With Anterior Cruciate Ligament Rupture
Official Title
A Cohort Study of Non-surgical Treatment and Exercise Rehabilitation in Patients -Chinese Population-based Cohort
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial compared the prognosis of surgical and non-surgical treatment in patients with complete anterior cruciate ligament rupture
Detailed Description
Anterior cruciate ligament injury is a common neuromuscular injury to the knee joint. The incidence rate is gradually increasing. There are 400,000 ACL reconstruction operations in the United States every year. The population of my country is equivalent to 4.3 times that of the United States. The potential economic burden of cruciate ligament reconstruction surgery on the country cannot be ignored. Anterior cruciate ligament reconstruction is seen as an effective treatment for this disease, avoiding secondary meniscus damage and knee degeneration, but the failure rate is still as high as 20%. In addition, problems such as poor bending angle caused by postoperative adhesions that may occur after surgery, atrophy of the quadriceps muscle of the patient's affected leg, and overstrain of the healthy leg caused by psychological factors may affect the quality of life after surgery. Reasons that prevent return to sports. The use of conservative treatment instead of surgery after recent ACL injury has received high attention, and a large number of RCTs have compared the benefits of surgery and conservative treatment.
Some reviews pointed out that the clinical outcomes of surgical treatment and conservative treatment are not much different, and even questioned the prognosis after anterior cruciate ligament reconstruction. Individual differentiated treatment is necessary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture, Osteoarthritis, Knee
Keywords
Anterior cruciate ligament (ACL), OA, non-surgical treatment, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients who were diagnosed with complete rupture of the ACL in the outpatient department of Peking University Third Hospital, the sports medicine doctor explained in detail (1) the way of conservative treatment, (2) the ruptured anterior cruciate ligament has the possibility of healing after fixation and (3) Willing to join the cohort study after enrollment. There were 60 subjects in the non-surgical treatment group and 60 in the surgical treatment group, for a total of 120 subjects.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
non-surgical treatment
Arm Type
Experimental
Arm Description
The patient who was diagnosed with complete rupture of the ACL in the Institute of Sports Medicine of the Third Hospital of Peking University was informed by the doctor that there is a chance that the ACL may grow back after 6 weeks of strict bracing.
Arm Title
surgical treatment
Arm Type
Active Comparator
Arm Description
The patient who was diagnosed with complete rupture of the ACL in the Institute of Sports Medicine of the Third Hospital of Peking University was informed by the doctor that there is a chance that after 6 weeks of strict brace immobilization, the ACL may grow back without surgery. However, the choice was still made for immediate ACL reconstruction.
This group of patients underwent anterior cruciate ligament reconstruction surgery in the Third Hospital of Peking University.
Intervention Type
Procedure
Intervention Name(s)
non surgical treatment
Intervention Description
Conservative treatment is required to use a curved splint for 6 weeks to keep the feet on the ground, bathing and sleeping without loosening the utensils and taking no steroids during the period. Physical examination and magnetic resonance imaging were performed after 6 weeks. If laxity remained unsatisfactory, the outcome was recorded as failure and surgery was changed.
Intervention Type
Procedure
Intervention Name(s)
surgical treatment
Intervention Description
The patient underwent knee arthroscopic anterior cruciate ligament surgery at the Institute of Sports Medicine of the Third Hospital of Peking University. The surgical methods were all anatomical single-bundle.
Primary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Description
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.The role of IKDC2000 is not only to compare the prognosis of the knee joint between the surgical group and the non-surgical group, but also to the normal population we mentioned in the article according to The International Knee Documentation Committee Subjective Knee Evaluation Form Normative Data Allen F. Anderson,*† AJSM The IKDC2000 values of different genders and ages were used to judge whether the two groups of patients reached the standard of normal people after surgery.
Time Frame
At 6 months after intervention.
Title
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form 2000
Description
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.The role of IKDC2000 is not only to compare the prognosis of the knee joint between the surgical group and the non-surgical group, but also to the normal population we mentioned in the article according to The International Knee Documentation Committee Subjective Knee Evaluation Form Normative Data Allen F. Anderson,*† AJSM The IKDC2000 values of different genders and ages were used to judge whether the two groups of patients reached the standard of normal people after surgery.
Time Frame
At 12 months after intervention.
Title
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Description
Patients will be asked to fill out the IKDC2000 score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.The role of IKDC2000 is not only to compare the prognosis of the knee joint between the surgical group and the non-surgical group, but also to the normal population we mentioned in the article according to The International Knee Documentation Committee Subjective Knee Evaluation Form Normative Data Allen F. Anderson,*† AJSM The IKDC2000 values of different genders and ages were used to judge whether the two groups of patients reached the standard of normal people after surgery.
Time Frame
At 24 months after intervention.
Title
Quadriceps strength
Description
Side to side quadriceps strength assessed by Biodex arthrometer test
Time Frame
At 24months after intervention.
Title
Knee laxity （physical exam）
Description
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Time Frame
At 24months after intervention.
Title
Knee laxity （KT-2000 arthrometer）
Description
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Time Frame
At 24months after intervention.
Title
Magnetic resonance imaging (MRI)
Description
Magnetic resonance imaging was used to compare lateral comparisons of ligament healing and ACL graft healing after conservative treatment, meniscal damage and knee cartilage damage after intervention.
Time Frame
At 24months after intervention.
Secondary Outcome Measure Information:
Title
Gender
Description
Measuring whether gender is a risk factor for anterior cruciate ligament reconstruction failure.
Time Frame
At baseline.
Title
Age
Description
Measuring whether age is a risk factor for anterior cruciate ligament reconstruction failure
Time Frame
At baseline
Title
BMI
Description
Weight and height will be combined to report BMI in kg/m^2. Measuring whether bmi is a risk factor for anterior cruciate ligament reconstruction failure
Time Frame
At baseline
Title
Single-Legged Hop Test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Time Frame
At 6 months after intervention.
Title
Single-Legged Hop Test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Time Frame
At 12 months after intervention.
Title
Single-Legged Hop Test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the single hop for distance.
Time Frame
At 24 months after intervention.
Title
Triple hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Time Frame
At 6 months after intervention.
Title
Triple hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Time Frame
At 12 months after intervention.
Title
Triple hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the triple hop for distance.
Time Frame
At 24 months after intervention.
Title
Cross hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Time Frame
At 6 months after intervention.
Title
Cross hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Time Frame
At 12 months after intervention.
Title
Cross hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the cross hop for distance.
Time Frame
At 24 months after intervention.
Title
6-m hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Time Frame
At 6 months after intervention.
Title
6-m hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Time Frame
At 12 months after intervention.
Title
6-m hop test
Description
The patients will perform three submaximal trial repetitions for familiarisation, after which three maximum effort trials are recorded. The uninvolved leg will test first at both inclusion sites. Record the 6-meter hop for time.
Time Frame
At 24 months after intervention.
Title
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
Description
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Time Frame
At 6 months after intervention.
Title
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
Description
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Time Frame
At 12 months after intervention.
Title
Knee Outcome Survey Activities of Daily Living (KOS-ADLS) Scale
Description
The ADLS is a 14 item scale that queries patients about how their knee symptoms effect their ability to perform general daily activities (6 items) as well as how their knee condition effects their ability to perform specific functional tasks (8 items). Each item is scored 0-5 with 5 indicating "no difficulty" and 0 representing "unable to perform". The highest possible score is 70. The scores of all items are summed, divided by 70, then multiplied by 100 to give an overall ADLS percent rating. Higher percentages reflect higher levels of functional ability. This scale would be appropriate for patients who either do not participate in sports or recreational activities or for those who have not yet progressed to performing these activities
Time Frame
At 24 months after intervention.
Title
Knee laxity
Description
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Time Frame
At 12 months after intervention.
Title
Knee laxity
Description
The side to side knee joint laxity of patients after anterior cruciate ligament surgery can be divided into four grades: grade A: -1~2mm(0+), grade B: 3~5mm (1+), grade C: 6~10mm (2+) and D Grade: >10mm(3+) assessed by Lachman test of physical examination.
Time Frame
At 6 months after intervention.
Title
Quadriceps strength
Description
Side to side quadriceps strength assessed by Biodex arthrometer test
Time Frame
At 6 months after intervention.
Title
Quadriceps strength
Description
Side to side quadriceps strength assessed by Biodex arthrometer test
Time Frame
At 12 months after intervention.
Title
Lysholm score
Description
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 6 months after intervention.
Title
Lysholm score
Description
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 12 months after intervention.
Title
Lysholm score
Description
Patients will be asked to fill out the Lysholm score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 24 months after intervention.
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 6 months after intervention.
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 12 months after intervention.
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Description
Patients will be asked to fill out the KOOS score to document the functional status. The minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 24 months after intervention.
Title
Tegner Score
Description
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Time Frame
At 6 months after intervention.
Title
Tegner Score
Description
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Time Frame
At 12 months after intervention.
Title
Tegner Score
Description
Patients will be asked to fill out the Tegner score to document the functional status. The minimum is 0 and the maximum value is 10. Higher scores mean a better outcome.
Time Frame
At 24 months after intervention.
Title
hort Form (SF)-36,The medical outcome study 36-items short form health survey (SF-36)
Description
Patients will be asked to fill out the SF-36 to document the quality of life . General health-related quality of life: SF-36 physical component score (range 0 to 100; higher score = better health state) at 2 yearsTh minimum is 0 and the maximum value is 100. Higher scores mean a better outcome.
Time Frame
At 6 months after intervention.
Title
Magnetic resonance imaging (MRI)
Description
Magnetic resonance imaging was used to compare lateral comparisons of ligament healing and ACL graft healing after conservative treatment, meniscal damage and knee cartilage damage after intervention.
Time Frame
At 6 months after intervention.
Title
Magnetic resonance imaging (MRI)
Description
Magnetic resonance imaging was used to compare lateral comparisons of ligament healing and ACL graft healing after conservative treatment, meniscal damage and knee cartilage damage after intervention.
Time Frame
At 12 months after intervention.
Title
Knee laxity （KT-2000 arthrometer）
Description
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Time Frame
At 6 months after intervention.
Title
Knee laxity （KT-2000 arthrometer）
Description
The knee laxity test of the forward KT-2000 measured knee laxity at pressures of 132Nt, 88Nt, 66Nt, and 44Nt, respectively, while the back-pushing KT-2000 was measured at -132NT, 88Nt, 66Nt, and -44Nt. The foward-pushing KT-2000 asessed side-to-side can be stratified into five levels are (A) < - 1 mm, (B) - 1 to 1 mm, (C) 1-3 mm, (D) 3-5 mm and (E) > 5 mm.
The back-pushing KT-2000 is also divided into side to side differences as (A) < - 2 mm, (B) - 2 to - 0.5 mm, (C) - 0.5 to 0.5 mm, (D) 0.5-1 mm and ( E) > 1 mm.
Time Frame
At 12 months after intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1) Age 8-45 years old 2) Complete rupture of unilateral anterior cruciate ligament (ACL) (with/without partial meniscus tear) 3) The history of ACL injury should not be more than 2 months before enrollment 4) Complete rupture of the ACL as determined by clinical examination and MRI 5) Activity level scale 5-9 (Tegner activity score) 6) Degeneration of knee joint <KL II degree, intraoperative cartilage injury < ICRS III degree.
7) The reason for the rupture of the anterior cruciate ligament is sports trauma.
8) Complete rupture of the ACL meets the MRI indications: (1) The signal changes, deforms, and thickens on imaging, and is completely broken but not separated; (2) There is no sagging and separation of the broken ends; (3) The synovial image is continuous.
9) The physical examination of complete ACL rupture meets the following indications: (1) Lachman (-) or ADT (-) has one of them; (2) or both are slightly loose, and the slack is not more than 10mm; (3) vertical Leg position ADT (-) or slack <5mm.
Exclusion Criteria:
1) Used in the previous 12 months 1. Intra-articular injection 2. Physical therapy 2) Those who broke again after surgery and underwent knee surgery in other hospitals 3) Previous knee surgery (except diagnostic arthroscopy) 4) Active infection of the knee joint within the past 12 months 5) Informed consent cannot be given 6) History of knee gout 7) Include one or more of the following knee-related injuries: 8) Unstable meniscus tears requiring repair or post-operative changes in rehabilitation Bicompartmental wide meniscectomy Total collateral ligament rupture full thickness cartilage lesions 9) History of rheumatoid arthritis or similar rheumatic diseases 10) The discovery of rheumatoid arthritis, rheumatoid arthritis pigment villonodular synovitis and other joint diseases during the postoperative follow-up period may impair the ability to participate in the study 11) Unable to speak/understand the research content, lack of autonomy, unable to walk, or unable to participate in follow-up 12) Participate in any drug trials during and after the disease 13) Any other medical condition that considers the longest survival time to be less than 2 years 14) Immunodeficiency or HIV positive 15) Illegal drug use or chronic alcoholism or total daily alcohol intake > 50 g/d 16) Pregnancy/planning pregnancy 17) There are contraindications such as current or previous history of neurological disease, cerebrovascular and serious cardiovascular disease, including coronary heart disease (angina pectoris, myocardial infarction, coronary angiogenesis process or abnormal electrocardiogram Q wave appearance (ECG)), Stroke (ischemic or hemorrhagic, including transient ischemic attack), peripheral arterial disease diagnosed by angiography 18) No imaging diagnosis 19) History of deep vein thrombosis (DVT) or blood system 20) There is a systemic disease that affects physical function, or there is any other condition or treatment that prevents the completion of the trial, including patients with metal devices or movement disorders
Facility Information:
Facility Name
Institute of Sports Medicine, Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia-kuo Yu, MD
Phone
86-10-82267392
Email
yujiakuo@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16219941
Citation
Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. Am J Sports Med. 2006 Jan;34(1):128-35. doi: 10.1177/0363546505280214. Epub 2005 Oct 11.
Results Reference
result
Learn more about this trial
A Cohort Study of Non-surgical Treatment and Exercise Rehabilitation in Patients With Anterior Cruciate Ligament Rupture
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