Actively Recruiting
Led by Karolinska Institutet · Updated on 2025-09-18
200
Participants Needed
1
Research Sites
417 weeks
Total Duration
Researchers are evaluating two types of grafts used in Anterior Cruciate Ligament Reconstruction (ACL-R) for athletes with a Tegner Activity Scale score of 7 or higher. This randomized controlled trial compares the semitendinosus hamstrings graft, the most common choice, with the quadriceps tendon-bone graft. Both grafts are well-known and are routinely registered in the Swedish ACL Registry, with the study sponsored by Karolinska Institutet. Participants will be randomly assigned to receive either the semitendinosus graft or the quadriceps tendon-bone graft during their ACL reconstruction surgery. The study aims to compare the knee laxity at 6 months post-operation as the primary outcome, with additional evaluations including patient-reported outcomes, graft site morbidity, return to sports rates, and post-operative rehabilitation. At 9 months, an MRI scan will assess graft maturity, and long-term follow-up at 5 and 10 years will include clinical scores and an X-ray to evaluate osteoarthritis development. During the study, participants will undergo various assessments at multiple time points before and after surgery, including knee laxity tests, functional knee tests, pain scores, questionnaires, and imaging. Researchers will also monitor return to sports and graft failure rates over time. The total participation period extends up to 10 years, allowing for comprehensive evaluation of both graft types and their long-term effects on knee function and health.
CONDITIONS
SEQUAR SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction
You may qualify if you...
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo Anterior Cruciate Ligament Reconstruction using either the Semitendinosus graft or Quadriceps tendon-bone graft technique.
1 surgical visit
Duration - Up to 24 months post-surgery
Participants attend multiple follow-up visits to monitor knee laxity, graft site morbidity, knee function, pain, and overall recovery including MRI assessment of graft maturity at 9 months.
Visits at 2 weeks, 6 weeks, 6 months, 9 months, 12 months, 18 months, and 24 months post-operative
Duration - Up to 10 years post-surgery
Participants are monitored long-term through registry data and imaging to assess graft failure, re-operation rates, osteoarthritis development, and functional outcomes up to 10 years.
Follow-up visits at 5 years and 10 years including imaging and questionnaires
Total: 1 location
1
Capio Artro Clinic AB
Stockholm, Stockholm County, Sweden, 11428
Actively Recruiting
A
Anders Stålman, MD,Phd
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Daniel Castellanos Dolk, Vasileios Sarakatsianos, Tobias Wörner...
https://pubmed.ncbi.nlm.nih.gov/41083992