Clinical trial NCT06980285: Comparison of Quadriceps and Semitendinosus Grafts in ACL Reconstruction Using Data From the Danish Knee Ligament Reconstruction Registry (DKRR)
Official title: ACL Reconstruction With Quadriceps Tendon Graft vs. Quadrupled Semitendinosus Graft: A Comparison of Patients From the Danish National ACL Reconstruction Database
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anterior Cruciate Ligament Injury
Knee Injury
Ligament Reconstruction
Sports Injuries
Keywords: ACL reconstruction
Quadriceps tendon graft
Semitendinosus graft
DKRR
Knee ligament injury
Orthopaedic surgery
Registry study
Lead sponsor: Søernes Privathospital
Sponsor class: OTHER
Collaborators: name: Søernes Privathospital
First posted: 2025-05-20
Enrollment: 2500
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered in the Danish Knee Ligament Reconstruction Registry (DKRR) who underwent primary anterior cruciate ligament reconstruction using either a quadriceps tendon graft or a semitendinosus tendon graft. All included patients have completed at least one year of follow-up and patient-reported outcome measures. The population consists of physically active individuals aged 15 to 50 years.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Primary ACL reconstruction registered in the Danish Knee Ligament Reconstruction Registry (DKRR)
* Known graft type: quadriceps tendon or semitendinosus tendon Minimum 1-year follow-up with completed patient-reported outcome measures (KOOS and/or Tegner score)
* Age between 15 and 50 years at the time of surgery (optional subgroup analysis)

Exclusion Criteria:

* Revision ACL reconstruction
* Multiligament knee reconstruction
* Missing or incomplete PROMs or key clinical data

Primary outcomes:
measure: The Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: At minimum 1 year follow up postoperatively
measure: Tegner Activity Score
timeFrame: Minimum 1 year follow up postoperatively.
Secondary outcomes:
measure: Re-operation rate
timeFrame: Within 1 year of surgery
measure: Postoperative complications
timeFrame: Within 1 year after surgery
measure: Patient satisfaction
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Søernes Privathospital
state: Frederiksberg
Study officials:
References: