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NCT Number: NCT06980285

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

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.

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Athletic Injuries Knee Injuries Knee Injury Leg Injuries Ligament Reconstruction Sports Injuries Wounds and Injuries

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: At minimum 1 year follow up postoperatively

    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

  2. Tegner Activity Score

    Time frame: Minimum 1 year follow up postoperatively.

    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

Secondary outcomes

  1. Re-operation rate

    Time frame: Within 1 year of surgery

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

  2. Postoperative complications

    Time frame: Within 1 year after surgery

    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

  3. Patient satisfaction

    Time frame: 1 year follow up

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdirahman Omar H Medical Students

CONTACT

[email protected]

+ 45 27 59 97 29

Mikkel Attrup L MD, Orthopedic Surgeon

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Abdirahman Hassan Omar

Other

Collaborators

  • Søernes Privathospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 20, 2025
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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