Back to resultsAllogeneic Bone-patellar Tendon-bone Transplantation
Primary Purpose
Anterior Cruciate Ligament Rupture
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
BPTB double-bundle allograft
BPTB single-bundle allograft group
BPTB single-bundle autograft group
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Rupture
Eligibility Criteria
Inclusion Criteria:
From July 2005 to June 2008, 3757 ACLRs were performed in our department. A total of 111 patients chose to use allografts, and the other patients chose autologous semitendinosus and gracilis tendons (STGs). The patients selected DB or SB reconstruction based on their understanding about the information from the surgeons. Following the criteria of a prospective randomized study, 56 patients undergoing ACLRs with BPTB allografts were included in our study and were divided into a DB group and a SB group, each with 28 patients. 25 DB and 27 SB patients completed the final follow-up. Only patients between 16 and 50 years old who were undergoing primary operation were included, and younger patients had to have radiographic confirmation of a closed epiphysis.
Exclusion Criteria:
The exclusion criteria included age more than 50 years, narrow middle intercondylar width (<12 mm measured during operation with the knee flexed to 90°), revision reconstruction, multiligament injury, bilateral ACLRs, total meniscectomy or more than one-third partial meniscectomy, and severe cartilage injury.
Sites / Locations
- Institute of Sports Medicine, Peking University Third Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
BPTB double-bundle allograft group
BPTB single-bundle allograft group
BPTB single-bundle autograft group
Arm Description
The patient underwent arthroscopic double-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
The patient underwent arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
The patient underwent arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft．
Outcomes
Primary Outcome Measures
side-to-side difference
The side-to-side difference was measured at final follow-up by KT-2000 arthrometer (MEDmetric, San Diego, California) at 15 lb, 20 lb, and 30 lb in 30° and 90° of flexion.
total anteroposterior (AP) laxity
the total AP laxity (by back-pushing KT-2000 arthrometer measurement) of the knee joint were measured. The technique of the back-pushing KT-2000 arthrometer is as follows: at 30° or 90° of flexion, the patient relaxed himself or herself; next, the examiner pushed back the handle of the KT-2000 arthrometer with 20-lb force and set the zero point of the arthrometer while the tibia was kept in a back position. Then, the examiner applied an anterior force of 15 lb, 20 lb, and 30 lb, respectively, and recorded the results as the total AP laxity of the knee joint.
pivot shift
The pivot shift test of the knee joint is a test with an accuracy of 99% in the detection of knee anterior cruciate ligament injury.
range of motion (ROM)
Knee joint range of motion. Normal flexion 0 to 130°, extension 0°, flexion internal rotation 0 to 30°, flexion external rotation 0 to 40°.
isokinetic muscle strength evaluation
muscle strength was evaluated by Biodex dynamometer (Biodex, Shirley, New York) according to the manufacturer's guidelines. Strength testing was performed for knee flexion and knee extension at 60 and 120 deg/s. The mean peak torque of 5 maximal repetitions for each velocity was assessed to analyze the quadriceps and hamstring isokinetic strength, and the results of the operated leg were expressed as a percentage of that of the nonoperated side.
Secondary Outcome Measures
International Knee Documentation Committee (IKDC) score
At present, it is recognized internationally that IKDC has relatively high reliability, effectiveness and sensitivity for the assessment of ligament injuries, especially anterior cruciate ligament injuries.
Tegner score
This score is widely used by exercise assessors for patients with knee joint disease. This scoring method divides the patient's exercise level into 0-10 points, 0 as disability, and 10 as being able to participate in national competitive sports.
Lysholm score
This score is often used together with the Tegner score. The scores of this scoring system are generally high and focus more on the assessment of daily activities rather than sports.
Full Information
NCT ID
NCT04951531
First Posted
June 27, 2021
Last Updated
June 27, 2021
Sponsor
Peking University Third Hospital
Collaborators
The First Affiliated Hospital of Anhui Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1. Study Identification
Unique Protocol Identification Number
NCT04951531
Brief Title
Allogeneic Bone-patellar Tendon-bone Transplantation
Official Title
Allogeneic Bone-patellar Tendon-bone Transplantation to Reconstruct the Knee Joint Anterior Cruciate Ligament
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2005 (Actual)
Primary Completion Date
June 1, 2011 (Actual)
Study Completion Date
June 1, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital
Collaborators
The First Affiliated Hospital of Anhui Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Objective To investigate the mid-term clinical effect of bone-patellar tendon-bone (BPTB) graft double-bundle reconstruction of the anterior cruciate ligament (ACL) of the knee joint under arthroscope.
Detailed Description
The purpose of the present study was to report a unique technique of Double-bundle anterior cruciate ligament reconstruction (DB-ACLR) with a bone-patellar tendon- bone (BPTB) allograftand compare the clinical outcome of the new technique with that of the nonanatomic conventional transtibial Single-bundle anterior cruciate ligament reconstruction (SB-ACLR) with a BPTB allograft. The hypothesis was that the DB-ACLR with a BPTB allograft is technically feasible and may be superior in restoring anterior and rotational stability of the knee joint. Meanwhile, the back-pushing KT- 2000 arthrometer was used to confirm whether there were advantages of DB-ACLR in total anteroposterior stability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BPTB double-bundle allograft group
Arm Type
Experimental
Arm Description
The patient underwent arthroscopic double-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
Arm Title
BPTB single-bundle allograft group
Arm Type
Active Comparator
Arm Description
The patient underwent arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
Arm Title
BPTB single-bundle autograft group
Arm Type
Active Comparator
Arm Description
The patient underwent arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft．
Intervention Type
Procedure
Intervention Name(s)
BPTB double-bundle allograft
Intervention Description
The patient underwent surgery of arthroscopic double-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
Intervention Type
Procedure
Intervention Name(s)
BPTB single-bundle allograft group
Intervention Description
The patient underwent surgery of arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
Intervention Type
Procedure
Intervention Name(s)
BPTB single-bundle autograft group
Intervention Description
The patient underwent surgery of arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft．
Primary Outcome Measure Information:
Title
side-to-side difference
Description
The side-to-side difference was measured at final follow-up by KT-2000 arthrometer (MEDmetric, San Diego, California) at 15 lb, 20 lb, and 30 lb in 30° and 90° of flexion.
Time Frame
Before and 2 to 5 years after the operation
Title
total anteroposterior (AP) laxity
Description
the total AP laxity (by back-pushing KT-2000 arthrometer measurement) of the knee joint were measured. The technique of the back-pushing KT-2000 arthrometer is as follows: at 30° or 90° of flexion, the patient relaxed himself or herself; next, the examiner pushed back the handle of the KT-2000 arthrometer with 20-lb force and set the zero point of the arthrometer while the tibia was kept in a back position. Then, the examiner applied an anterior force of 15 lb, 20 lb, and 30 lb, respectively, and recorded the results as the total AP laxity of the knee joint.
Time Frame
Before and 2 to 5 years after the operation
Title
pivot shift
Description
The pivot shift test of the knee joint is a test with an accuracy of 99% in the detection of knee anterior cruciate ligament injury.
Time Frame
Before and 2 to 5 years after the operation
Title
range of motion (ROM)
Description
Knee joint range of motion. Normal flexion 0 to 130°, extension 0°, flexion internal rotation 0 to 30°, flexion external rotation 0 to 40°.
Time Frame
Before and 2 to 5 years after the operation
Title
isokinetic muscle strength evaluation
Description
muscle strength was evaluated by Biodex dynamometer (Biodex, Shirley, New York) according to the manufacturer's guidelines. Strength testing was performed for knee flexion and knee extension at 60 and 120 deg/s. The mean peak torque of 5 maximal repetitions for each velocity was assessed to analyze the quadriceps and hamstring isokinetic strength, and the results of the operated leg were expressed as a percentage of that of the nonoperated side.
Time Frame
Before and 2 to 5 years after the operation
Secondary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC) score
Description
At present, it is recognized internationally that IKDC has relatively high reliability, effectiveness and sensitivity for the assessment of ligament injuries, especially anterior cruciate ligament injuries.
Time Frame
Before and 2 to 5 years after the operation
Title
Tegner score
Description
This score is widely used by exercise assessors for patients with knee joint disease. This scoring method divides the patient's exercise level into 0-10 points, 0 as disability, and 10 as being able to participate in national competitive sports.
Time Frame
Before and 2 to 5 years after the operation
Title
Lysholm score
Description
This score is often used together with the Tegner score. The scores of this scoring system are generally high and focus more on the assessment of daily activities rather than sports.
Time Frame
Before and 2 to 5 years after the operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
From July 2005 to June 2008, 3757 ACLRs were performed in our department. A total of 111 patients chose to use allografts, and the other patients chose autologous semitendinosus and gracilis tendons (STGs). The patients selected DB or SB reconstruction based on their understanding about the information from the surgeons. Following the criteria of a prospective randomized study, 56 patients undergoing ACLRs with BPTB allografts were included in our study and were divided into a DB group and a SB group, each with 28 patients. 25 DB and 27 SB patients completed the final follow-up. Only patients between 16 and 50 years old who were undergoing primary operation were included, and younger patients had to have radiographic confirmation of a closed epiphysis.
Exclusion Criteria:
The exclusion criteria included age more than 50 years, narrow middle intercondylar width (<12 mm measured during operation with the knee flexed to 90°), revision reconstruction, multiligament injury, bilateral ACLRs, total meniscectomy or more than one-third partial meniscectomy, and severe cartilage injury.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia-kuo Yu, Prof.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Institute of Sports Medicine, Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Allogeneic Bone-patellar Tendon-bone Transplantation
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