NCT06980285

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 12, 2025

Last Update Submit

May 12, 2025

Conditions

Anterior Cruciate Ligament InjuryKnee InjuryLigament ReconstructionSports Injuries

Keywords

ACL reconstructionQuadriceps tendon graftSemitendinosus graftDKRRKnee ligament injuryOrthopaedic surgeryRegistry study

Outcome Measures

Primary Outcomes (2)

  • 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

    At minimum 1 year follow up postoperatively

  • 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

    Minimum 1 year follow up postoperatively.

Secondary Outcomes (3)

  • Re-operation rate

    Within 1 year of surgery

  • Postoperative complications

    Within 1 year after surgery

  • Patient satisfaction

    1 year follow up

Study Arms (2)

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).

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).

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Søernes Privathospital

Copenhagen, Frederiksberg, 1900, Denmark

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKnee InjuriesAthletic Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Central Study Contacts

Abdirahman Omar H Medical Students

CONTACT

+ 45 27 59 97 29Namharidba2@gmail.com

Mikkel Attrup L MD, Orthopedic Surgeon

CONTACT

Mikkel@attrup.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical student, Principal incestigator

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 20, 2025

Study Start

June 1, 2025

Primary Completion

September 30, 2025

Study Completion

November 30, 2025

Last Updated

May 20, 2025

Record last verified: 2025-05

Locations

DK(1)