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

NCT ID: NCT06980285

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-11-30

Brief Summary

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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

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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

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Anterior Cruciate Ligament Injury Knee Injury Ligament Reconstruction Sports Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Quadriceps tendon graft

Patients who underwent primary ACL reconstruction using a quadriceps tendon autograft, with or without a bone block. Data are derived retrospectively from the Danish Knee Ligament Reconstruction Registry (DKRR).

No interventions assigned to this group

Semitendinosus graft

Patients who underwent primary ACL reconstruction using a quadrupled semitendinosus tendon autograft. Data are derived retrospectively from the Danish Knee Ligament Reconstruction Registry (DKRR).

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Søernes Privathospital

OTHER

Sponsor Role collaborator

Abdirahman Hassan Omar

OTHER

Sponsor Role lead

Responsible Party

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Abdirahman Hassan Omar

Medical student, Principal incestigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Søernes Privathospital

Copenhagen, Frederiksberg, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Abdirahman Omar H Medical Students

Role: CONTACT

+ 45 27 59 97 29

Mikkel Attrup L MD, Orthopedic Surgeon

Role: CONTACT

Facility Contacts

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Abdirahman Omar H Medical strudent

Role: primary

+ 45 27 59 97 29

Other Identifiers

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SOPH-ACL-3+25

Identifier Type: -

Identifier Source: org_study_id

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