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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15-50
SponsorAbdirahman Hassan Omar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Revision ACL reconstruction

Multiligament knee reconstruction

Missing or incomplete PROMs or key clinical data

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

2,500 Participants
are grouped into 2 trial groups
Group A: Quadriceps tendon graft
Group B: Semitendinosus graft

Trial outcomes

Primary outcomes

1

The Knee Injury and Osteoarthritis Outcome Score (KOOS)

The Knee Injury and Osteoarthritis Outcome Score (KOOS) evaluates pain, symptoms, daily living, sport/recreation, and knee-related quality of life. Metric type: continuous PROM-based subscale score Method of measurement: Self reported questionnaire

Time frame
At minimum 1 year follow up postoperatively
2

Tegner Activity Score

Assesses patients' level of physical activity before injury and at follow-up. Metric type: Scale from 0-10, where 0 is no physical activity caused by knee problems and 10 is an ability to compete in elite level sport like soccer and ski. Method of measurement: Tegner scale, self reported

Time frame
Minimum 1 year follow up postoperatively.

Secondary outcomes

1

Re-operation rate

Incidence of surgical re-intervention after primary ACL reconstruction. Method of measurement: Registry recorded re-operations in DKRR

Time frame
Within 1 year of surgery
2

Postoperative complications

Frequency of postoperative complications such as infection, stiffness, or graft failure. Metric type: Occurrence of postoperative complications Method of measurement: Clinically reported and registry documented complications in DKRR

Time frame
Within 1 year after surgery
3

Patient satisfaction

Overall patient satisfaction with surgical outcome, if available in registry. Metric type: PROM's available from the DKRR Method of measurement: Patient reported satisfaction score.

Time frame
1 year follow up

Other outcomes

Sponsors and contacts

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Abdirahman Hassan Omar

Lead sponsor

Søernes Privathospital

Sponsor institution

Søernes Privathospital

Collaborator

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