Long Term Clinical and Radiographical Outcomes of Different Anterior Cruciate Ligament Reconstruction Techniques
Primary Purpose
Anterior Cruciate Ligament Tear, Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Anatomical single bundle ACL reconstruction with hamstrings
Anatomical single bundle ACL reconstruction with patellar tendon
ACL reconstruction with over the top plus lateral plasty technique
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring anterior cruciate ligament, knee osteoarthritis, hamstrings, patellar tendon, lateral extra articular tenodesis
Eligibility Criteria
Inclusion Criteria:
- Patients who underwent ACL reconstruction with single-bundle anatomical technique (patellar tendon, semitendinous and gracile tendons) or "Over-The-Top plus lateral plastic" technique and any associated procedures with at least 15 years of follow up;
- Patients aged between 15 and 50 at the time of surgery;
- Patients with isolated ACL tear;
- Patients with healthy contralateral knee at the time of surgery.
Exclusion Criteria:
- Patients with grade III-IV chondral lesions according to Outerbridge scale at surgery;
- Patients no longer available;
- Women of childbearing age who cannot exclude pregnancy;
- Patients unable to give informed consent or patients unwilling to sign informed consent.
Sites / Locations
- Istituto Ortopedico Rizzoli
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
HS
BPT
Over-the-top plus lateral plasty
Arm Description
Patients who underwent anatomical single-bundle ACL reconstruction with hamstrings
Patients who underwent anatomical single-bundle ACL reconstruction with patellar tendon
Patients who underwent ACL reconstruction with Over-the-top plus lateral plasty technique
Outcomes
Primary Outcome Measures
Subjective and objective International Knee Documentation Committee
Clinical scores widely used to assess knee function and symptoms Values: 0 (worst score) to 100 (best score) for subjective IKDC; A (best score)-B-C-D (worst score) for objective IKDC (International Knee Documentation Committee)
VAS pain
Numerical score to quantitatively assess the intensity of pain (0-10)
Kellgreen-Lawrence
Radiographical score that graded knee ostheoarthritis
Knee Laxity
Assessment of knee anterior posterior laxity and quantification of Pivot shift using measurement devices (KT-1000; Kira)
Failure and complications
Failures and complication rate for each arm of the study
Secondary Outcome Measures
Short Form-36 Health Survey
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.
Anterior knee pain
The patients will report in dicotomic way (yes/no) the presence/absence of pain referred to patello-femural joint.
Global satisfaction about the surgical procedure
The patients will report in dicotomic way (yes/no) if they are satisfied with the surgical procedure results
Tight circumference
Tight circumference measured 5 cm and 15 cm above the patella; it is a direct measurement of quadriceps trophism and indirectly explore the muscular status of affected limb.
Lysholm knee scoring scale
Clinical score used to assess knee function in context of ligamentary and meniscal lesions Values: 0 (worst score) to 100 (best score)
Tegner activity scale
Score that graded activity based on work and sports referred to knee status Values: 0 (worst score) to 10 (best score)
Full Information
NCT ID
NCT05088278
First Posted
October 12, 2021
Last Updated
July 27, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT05088278
Brief Title
Long Term Clinical and Radiographical Outcomes of Different Anterior Cruciate Ligament Reconstruction Techniques
Official Title
Long Term Clinical and Radiographical Outcomes of Different Anterior Cruciate Ligament Reconstruction Techniques
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
July 27, 2023 (Actual)
Study Completion Date
July 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
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
The purpose of this study is to evaluate the long-term results of various anterior cruciate ligament reconstruction techniques. This assessment is necessary for the current context of anterior cruciate ligament research as several techniques and grafts are used in clinical practice, however, the various studies existing in the literature focus mainly only on the direct comparison of two techniques and usually with short-to-medium term follow-up. Since gonarthrosis is one of the most debated consequences of cruciate ligament reconstruction, a comparison of different long-term procedures would be desirable to have a clearer picture of the risks and benefits associated with different types of intervention.
Detailed Description
In the beginning, the Database of our Institute is consulted, all the patients that underwent ACL reconstruction at least 15 years ago are selected. The original group will be divided into subgroups based on the surgical technique adopted, of the different techniques we took into consideration only these three: anatomical ACL reconstruction with patellar tendon, anatomical ACL reconstruction with hamstrings, non-anatomical ACL reconstruction "Over-the-top plus lateral plasty". The patients will be contacted to ask if they are interested to take part in the study; at least 25 patients for each group will be recruited. All the patients recruited will sign an informed consent about the study and the personal data treatment. After consent acquisition, patients will undergo a clinical examination and a questionnaire about pain and knee status will be administered; moreover, a radiographical examination of the operated knee will be performed to assess the osteoarthritis progression. Patients that reported graft rupture will be registered as failures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear, Osteoarthritis, Knee
Keywords
anterior cruciate ligament, knee osteoarthritis, hamstrings, patellar tendon, lateral extra articular tenodesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HS
Arm Type
Active Comparator
Arm Description
Patients who underwent anatomical single-bundle ACL reconstruction with hamstrings
Arm Title
BPT
Arm Type
Active Comparator
Arm Description
Patients who underwent anatomical single-bundle ACL reconstruction with patellar tendon
Arm Title
Over-the-top plus lateral plasty
Arm Type
Experimental
Arm Description
Patients who underwent ACL reconstruction with Over-the-top plus lateral plasty technique
Intervention Type
Procedure
Intervention Name(s)
Anatomical single bundle ACL reconstruction with hamstrings
Intervention Description
Anatomical ACL reconstruction with quadruple-bundle hamstrings graft
Intervention Type
Procedure
Intervention Name(s)
Anatomical single bundle ACL reconstruction with patellar tendon
Intervention Description
Anatomical single bundle ACL reconstruction with patellar tendon
Intervention Type
Procedure
Intervention Name(s)
ACL reconstruction with over the top plus lateral plasty technique
Intervention Description
Non-anatomical ACL reconstruction, the hamstrings' tibial insertion is preserved; a double-bundle hamstring graft is passed intra-articularly, fixed in over the top position on the lateral femoral condyle, and then passed extra-articularly deeply to ileo-tibial band up to the tibia, where it is fixed at the level of Gerdy's tubercle.
Primary Outcome Measure Information:
Title
Subjective and objective International Knee Documentation Committee
Description
Clinical scores widely used to assess knee function and symptoms Values: 0 (worst score) to 100 (best score) for subjective IKDC; A (best score)-B-C-D (worst score) for objective IKDC (International Knee Documentation Committee)
Time Frame
Two years
Title
VAS pain
Description
Numerical score to quantitatively assess the intensity of pain (0-10)
Time Frame
Two years
Title
Kellgreen-Lawrence
Description
Radiographical score that graded knee ostheoarthritis
Time Frame
Two years
Title
Knee Laxity
Description
Assessment of knee anterior posterior laxity and quantification of Pivot shift using measurement devices (KT-1000; Kira)
Time Frame
Two years
Title
Failure and complications
Description
Failures and complication rate for each arm of the study
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Short Form-36 Health Survey
Description
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.
Time Frame
Two years
Title
Anterior knee pain
Description
The patients will report in dicotomic way (yes/no) the presence/absence of pain referred to patello-femural joint.
Time Frame
Two years
Title
Global satisfaction about the surgical procedure
Description
The patients will report in dicotomic way (yes/no) if they are satisfied with the surgical procedure results
Time Frame
Two years
Title
Tight circumference
Description
Tight circumference measured 5 cm and 15 cm above the patella; it is a direct measurement of quadriceps trophism and indirectly explore the muscular status of affected limb.
Time Frame
Two years
Title
Lysholm knee scoring scale
Description
Clinical score used to assess knee function in context of ligamentary and meniscal lesions Values: 0 (worst score) to 100 (best score)
Time Frame
Two years
Title
Tegner activity scale
Description
Score that graded activity based on work and sports referred to knee status Values: 0 (worst score) to 10 (best score)
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who underwent ACL reconstruction with single-bundle anatomical technique (patellar tendon, semitendinous and gracile tendons) or "Over-The-Top plus lateral plastic" technique and any associated procedures with at least 15 years of follow up;
Patients aged between 15 and 50 at the time of surgery;
Patients with isolated ACL tear;
Patients with healthy contralateral knee at the time of surgery.
Exclusion Criteria:
Patients with grade III-IV chondral lesions according to Outerbridge scale at surgery;
Patients no longer available;
Women of childbearing age who cannot exclude pregnancy;
Patients unable to give informed consent or patients unwilling to sign informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Zaffagnini, MD Prof
Organizational Affiliation
Istituto Ortopedico Rizzoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
28205075
Citation
Samuelsen BT, Webster KE, Johnson NR, Hewett TE, Krych AJ. Hamstring Autograft versus Patellar Tendon Autograft for ACL Reconstruction: Is There a Difference in Graft Failure Rate? A Meta-analysis of 47,613 Patients. Clin Orthop Relat Res. 2017 Oct;475(10):2459-2468. doi: 10.1007/s11999-017-5278-9.
Results Reference
background
PubMed Identifier
32147485
Citation
Getgood A, Hewison C, Bryant D, Litchfield R, Heard M, Buchko G, Hiemstra LA, Willits KR, Firth A, MacDonald P; Stability Study Group. No Difference in Functional Outcomes When Lateral Extra-Articular Tenodesis Is Added to Anterior Cruciate Ligament Reconstruction in Young Active Patients: The Stability Study. Arthroscopy. 2020 Jun;36(6):1690-1701. doi: 10.1016/j.arthro.2020.02.015. Epub 2020 Mar 6.
Results Reference
background
PubMed Identifier
28922015
Citation
Zaffagnini S, Marcheggiani Muccioli GM, Grassi A, Roberti di Sarsina T, Raggi F, Signorelli C, Urrizola F, Spinnato P, Rimondi E, Marcacci M. Over-the-top ACL Reconstruction Plus Extra-articular Lateral Tenodesis With Hamstring Tendon Grafts: Prospective Evaluation With 20-Year Minimum Follow-up. Am J Sports Med. 2017 Dec;45(14):3233-3242. doi: 10.1177/0363546517723013. Epub 2017 Sep 18.
Results Reference
background
PubMed Identifier
24748500
Citation
Xie X, Xiao Z, Li Q, Zhu B, Chen J, Chen H, Yang F, Chen Y, Lai Q, Liu X. Increased incidence of osteoarthritis of knee joint after ACL reconstruction with bone-patellar tendon-bone autografts than hamstring autografts: a meta-analysis of 1,443 patients at a minimum of 5 years. Eur J Orthop Surg Traumatol. 2015 Jan;25(1):149-59. doi: 10.1007/s00590-014-1459-3. Epub 2014 Apr 21.
Results Reference
background
PubMed Identifier
30790526
Citation
Mouarbes D, Menetrey J, Marot V, Courtot L, Berard E, Cavaignac E. Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis of Outcomes for Quadriceps Tendon Autograft Versus Bone-Patellar Tendon-Bone and Hamstring-Tendon Autografts. Am J Sports Med. 2019 Dec;47(14):3531-3540. doi: 10.1177/0363546518825340. Epub 2019 Feb 21.
Results Reference
background
PubMed Identifier
32387652
Citation
Chen H, Liu H, Chen L. Patellar Tendon Versus 4-Strand Semitendinosus and Gracilis Autografts for Anterior Cruciate Ligament Reconstruction: A Meta-analysis of Randomized Controlled Trials With Mid- to Long-Term Follow-Up. Arthroscopy. 2020 Aug;36(8):2279-2291.e8. doi: 10.1016/j.arthro.2020.04.024. Epub 2020 May 7.
Results Reference
background
PubMed Identifier
32019734
Citation
Curado J, Hulet C, Hardy P, Jenny JY, Rousseau R, Lucet A, Steltzlen C, Morin V, Grimaud O, Bouguennec N, Pujol N, Sonnery-Cottet B, Graveleau N; French Society for Orthopaedic, Trauma Surgery (Societe francaise de chirurgie orthopedique et traumatologique, SoFCOT). Very long-term osteoarthritis rate after anterior cruciate ligament reconstruction: 182 cases with 22-year' follow-up. Orthop Traumatol Surg Res. 2020 May;106(3):459-463. doi: 10.1016/j.otsr.2019.09.034. Epub 2020 Feb 1.
Results Reference
background
PubMed Identifier
16909301
Citation
Zaffagnini S, Marcacci M, Lo Presti M, Giordano G, Iacono F, Neri MP. Prospective and randomized evaluation of ACL reconstruction with three techniques: a clinical and radiographic evaluation at 5 years follow-up. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1060-9. doi: 10.1007/s00167-006-0130-x. Epub 2006 Aug 15.
Results Reference
result
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Long Term Clinical and Radiographical Outcomes of Different Anterior Cruciate Ligament Reconstruction Techniques
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