Comparing two types of grafts for knee ligament surgery
SEQUAR - SEmitendinosus vs QUadriceps in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Study
This study is testing which type of graft works better for knee ligament surgery in athletes who have injured their ACL.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 16 Years to 40 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Stockholm County) |
| Trial ID | NCT04295148 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different grafts used in Anterior Cruciate Ligament (ACL) reconstruction: the semitendinosus hamstrings graft and the quadriceps tendon graft. Conducted at Capio Artro Clinic in Stockholm, the study involves a randomized control design with 200 athletes who have sustained ACL injuries. Participants will be monitored over a two-year period to assess outcomes such as knee laxity, return to sports, and graft maturity through MRI scans. The study aims to provide insights into which graft may offer better long-term results for athletes.
Who should consider this trial
Good fit: Ideal candidates are athletes with a verified ACL rupture who have a pre-injury Tegner Activity Scale of 7 or higher and intend to return to their previous level of sports activity.
Not a fit: Patients with previous knee injuries, significant ligament laxity, or other complicating medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for athletes undergoing ACL reconstruction.
How similar studies have performed: Previous studies have shown varying success with different graft types in ACL reconstruction, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pre-injury Tegner Activity Scale≥7 * Intended return to sports to prior sport and Tegner Activity Scale Level * Time between injury and inclusion not more than 6 months * MR verified ACL rupture Exclusion Criteria: * Previous knee injury with symptoms before ACL injury * Neurological disease, inflammatory disease, connective tissue disease or balance disorder * Previous lower limb fracture or surgery * Laxity in the medial collateral ligament (MCL) and lateral collateral ligament (LCL) \> grade 1 * PCL rupture or Multiligament knee injury (MLKI) * Radiographic sign of osteoarthritis (OA) * Previous knee surgery or ligament injury in contralateral knee * Beighton score ≥ 5
Where this trial is running
Stockholm, Stockholm County
- Capio Artro Clinic AB — Stockholm, Stockholm County, Sweden (Recruiting)
Study contacts
- Principal investigator: Anders Stålman, MD,PhD — Karolinska Institutet
- Study coordinator: Anders Stålman, MD,Phd
- Email: anders.stalman@ki.se
- Phone: 0046736665957
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.