Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT06980285

Comparison of Quadriceps and Semitendinosus Grafts in ACL Reconstruction Using Data From the Danish Knee Ligament Reconstruction Registry (DKRR)

ACL Reconstruction With Quadriceps Tendon Graft vs. Quadrupled Semitendinosus Graft: A Comparison of Patients From the Danish National ACL Reconstruction Database

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
2,500 (estimated)
Sponsor
Abdirahman Hassan Omar · Academic / Other
Sex
All
Age
15 Years – 50 Years
Healthy volunteers
Not accepted

Summary

This study looks at two different types of tendon (tissue) used in knee surgery to repair a torn anterior cruciate ligament (ACL), which is a common injury in active people. The two types are taken from different muscles in the thigh: one from the front (quadriceps) and one from the back (semitendinosus). We will use information already collected in a national health registry to see how patients recover after surgery. The study will compare knee function, activity level, and how often patients need another operation.

Detailed description

This is a retrospective observational cohort study based on data from the Danish Knee Ligament Reconstruction Registry (DKRR). The study includes patients who underwent primary ACL reconstruction using either a quadriceps tendon graft (with or without a bone block) or a quadrupled semitendinosus tendon graft. The primary outcome measures are the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Tegner Activity Scale. Secondary outcomes include reoperation rates, postoperative complications, and patient satisfaction. All available demographic, operative, and patient-reported outcome data will be analyzed. Multivariable regression will be used to adjust for confounders such as age, sex, BMI, time from injury to surgery, and surgeon volume. The study is exempt from ethical approval under Danish law, and data will be handled in compliance with GDPR.

Conditions

Timeline

Start date
2025-06-01
Primary completion
2025-09-30
Completion
2025-11-30
First posted
2025-05-20
Last updated
2025-05-20

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT06980285. Inclusion in this directory is not an endorsement.