SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Tear
• Interventions: Procedure: ACL Reconstruction with Quadriceps tendon-bone graft; Procedure: ACL Reconstruction with Semitendinosus graft

• Registration Number: NCT04295148
• Lead Sponsor: Karolinska Institutet

Brief Summary

Randomized control trial comparing two different Anterior Cruciate Ligament (ACL) grafts in Anterior Cruciate Ligament Reconstruction: the semitendinosus hamstrings graft and the quadriceps graft. Capio Artro Clinic (Stockholm) has vast experience in ACL surgery using both semitendinosus and quadriceps grafts.

Detailed Description

The purpose of the study is to evaluate the quadriceps graft with bone-plug in Anterior Cruciate Ligament Reconstruction (ACL-R) and compare it with Sweden's standard choice of graft, semitendinosus graft in ACL-R in higher level athletes with Tegner Activity Scale 7 or higher. Both methods are well-known and continually registered in the Swedish ACL Registry. Patients will be followed up during a 2-year period.

Both grafts will be compared post operatively as to laxity, PROM, as well as measure graft site morbidity, Return to Sports rate, and the post-operative rehab. At 9 months we will also preform a MRI scan to determine graft maturity. 5-year and 10-year data will also be acquired through the Swedish ACL-registry and Lysholm score and Tegner Activity Level score. At 10-year a plain weight baring X-ray will be preformed to evaluate development of osteoarthritis.Both methods are well-known and continually registered in the Swedish ACL Registry.

The study design is a prospective randomized study with equal groups:

Semitendinosus graft (=100) and Quadriceps tendon graft (n=100). According to historical material from Capio Artro Clinic (Stockholm) the following power calculation has been made: Significance lever 5 percent (p=0.05) and power is 80%. The difference between the groups is 1 mm knee laxity with KT-1000 which would give an effect size of 0,44 or less compared to an average effect size (0,50). 85 individuals will be needed in each group in the statistical analysis. Stratifying according to gender will be done with 40% female and 60 % males, as this represent the prevalence of ACL reconstruction in our clinic and in the Swedish ACL registry. It is known the females have a higher rerupture rate and lower subjective outcome. Inclusion will continue until we have 100 individuals in each group according to the stratification. This means that each group can have more than 100 individuals. Randomization process and study design will be done according to the CONSORT guidelines.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-10
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-09
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Primary ACL reconstruction for patients with Tegner score equal or higher than 7 before injury.

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Exclusion Criteria

• Multiligament knee injury
• Former knee operation
• Former fracture
• Inflammatory disease
• More than one ligamentous injury in the same knee requiring reconstructive surgery
• Former ACL injury in the contralateral knee
• Reconstruction of ACL in the contralateral knee during the study follow up period
• Lack av baseline pre- or postoperative data (KT-1000, KOOS, Lysholm Score, EQ-5D)
• Any other situation preventing patient from participating in extensive follow up.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadriceps tendon-bone graft	ACL Reconstruction with Quadriceps tendon-bone graft	Participants receive the Quadriceps Tendon-Bone Graft technique during ACL reconstruction.
Semitendinosus graft	ACL Reconstruction with Semitendinosus graft	Participants receive the Semitendinosus Graft technique during ACL reconstruction.

Primary Outcome Measures

Name	Time	Method
Change from Baseline KOOS (the Knee Injury and Osteoarthritis Outcome Score) at 24 months	Pre-operative appointment and 24 months	Patients will complete the KOOS surveys at pre-operatively and at 2 years time post-operatively to evaluate subjective knee function
Change from Baseline KT-1000 Knee Laxity at 6 months	Pre-operative appointment and 6 months post-operative appointments	The KT-1000 measures laxity objective- and parametrically and is a validated tool for establishing joint laxity post operatively in mm.

Secondary Outcome Measures

Name	Time	Method
IKDC	Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments	Patients will complete the IKDC at specific time points to evaluate subjective knee function throughout treatment.
PAS	Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments	Patients will complete the PAS at specific time points to evaluate subjective knee function throughout treatment
KOOS	Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments	Patients will complete the KOOS at specific time points to evaluate subjective knee function throughout treatment
Kartus anterior knee pain score	6 weeks, 6 months, 9 months, and 12 months	Patients will complete Kartus anterior knee pain score at specific time points to evaluate graft site pain/morbidity throughout treatment
Graft site morbidity questionnaire	6 weeks, 6 months, 12 months, 24 months	Patients will complete additional survey questions at specific time points to evaluate graft site pain/morbidity throughout treatment
Goniometric measurement: Knee extension and flexion	2 weeks, 6 weeks, 6 months, 9 months and 12 months	Patients will undergo goniometric measurement at specific time points to evaluate knee moment throughout treatment.
Measurement of circumference of the knee	2 weeks, 6 weeks, 6 months, 9 months and 12 months	Circumference of the knee will be measured at mid-patella and 15 cm above superior border of the patella. They will be compared with the contralateral knee to compare knee swelling.
Biodex Isokinetic Measurement	6 months and 12 months	Patients will undergo Biodex Isokinetic measurement at specific time points to muscle strength throughout treatment.
Functional knee tests	6 months, 9 months and 12 months	Patients will undergo functional knee test (ie one legged jump and crossover jump) at specific time points to evaluate functional knee movement throughout treatment.
Lachmans test	Pre-operative appointment , 6 months, 9 months and 12 months	Patients will undergo passive accessory stability tests Lachmans test (graded 0,1,2 and 3) at specific time points to evaluate passive knee laxity throughout treatment.
Pivot shift test	Pre-operative appointment , 6 months, 9 months and 12 months	Patients will undergo passive accessory stability tests pivot shift test (graded 0,1,2 and 3) at specific time points to evaluate passive knee laxity throughout treatment.
Time to Return to Sports Rates	6 months, 9 months, 12 months, 18 months, 24 months	Time to return to sports will be evaluated through Return to Sport surveys at specific time points throughout treatment
Graft failure rate or ACL re-rupture	10 years	ACL reconstruction will be evaluated by graft failure rate or ACL re-rupture during a 10 year period
ACL re-operation	10 years	ACL reconstruction will be evaluated by re-operation rate during a 10 year period
Graft maturity	9 months	Graft maturity after ACL reconstruction will be evaluated by MRI at 9 months postoperatively.
10 year X-Ray	10 years	Development of osteoarthritis after ACL reconstruction will be evaluated by plain weight baring X-rays at 10 years.
EQ5D	Pre-operative appointment, 12 months, 24 months, 5 years and 10 years post-operative appointments	Patients will complete the EQ5D at specific time points to evaluate subjective knee function throughout treatment
Lysholm score	Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments	Patients will complete the Lysholm score at specific time points to evaluate subjective knee function throughout treatment
Tegner Activity Score	Pre-operative appointment, 6 months, 9 months, 12 months, 18 months, 24 months, 5 years and 10 years post-operative appointments	Patients will complete the Tegner Activity score at specific time points to evaluate level of sports activity postoperatively.
ACL-RSI	6 months and 12 months, post-operative appointments	Patients will complete the ACL-RSI surveys at specific time points to evaluate self efficacy and readiness to return to sports throughout treatment
Return to Sports Questionnaire	6 months, 9 months and 12 months, 18 months, and 24 months post-operative appointments	Patients will complete the a Return to Sports Questionnaire at specific time points to evaluate return to sports after 6 and 12 months throughout treatment
Werner anterior knee pain score	6 weeks, 6 months, 9 months, and 12 months	Patients will complete Werner anterior knee pain scores at specific time points to evaluate graft site pain/morbidity throughout treatment

Trial Locations

Locations (1)

Capio Artro Clinic AB; 🇸🇪 Stockholm, Sweden