Anterior Cruciate Ligament InjuryNCT06980285
Comparison of Quadriceps and Semitendinosus Grafts in ACL Reconstruction Using Data From the Danish Knee Ligament Reconstruction Registry (DKRR)
An observational study of Anterior Cruciate Ligament Injury and Knee Injury, run by Abdirahman Hassan Omar at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Knee Injury, Ligament Reconstruction
- How many people
- 2,500 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2025to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- Revision ACL reconstruction
- Multiligament knee reconstruction
- Missing or incomplete PROMs or key clinical data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mikkel Attrup L MD, Orthopedic Surgeon contact
Denmark1 site
Søernes Privathospital
Copenhagen, Frederiksberg, 1900
Abdirahman Omar H Medical strudent, + 45 27 59 97 29, namharidba2@gmail.com
About this study
Official title: ACL Reconstruction With Quadriceps Tendon Graft vs. Quadrupled Semitendinosus Graft: A Comparison of Patients From the Danish National ACL Reconstruction Database
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.
Read the 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.
- Keywords
- ACL reconstruction, Quadriceps tendon graft, Semitendinosus graft, DKRR, Knee ligament injury, Orthopaedic surgery, Registry study
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Knee Injuries, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Minimum 1 year follow up postoperatively.
Secondary outcomes (3)
Re-operation rate
Incidence of surgical re-intervention after primary ACL reconstruction. Method of measurement: Registry recorded re-operations in DKRR
Measured: Within 1 year of surgery
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
Measured: Within 1 year after surgery
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.
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abdirahman Hassan Omar
- Sponsor type
- University, hospital or other
- Collaborators
- Søernes Privathospital
- Responsible party
- Sponsor-investigator, Abdirahman Hassan Omar, Søernes Privathospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980285
- Sponsor's protocol ID
- SOPH-ACL-3+25
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACL Reconstruction With Quadriceps Tendon Graft vs. Quadrupled Semitendinosus Graft: A Comparison of Patients From the Danish National ACL Reconstruction Database
- ClinicalTrials.gov ID
- NCT06980285
- Acronym / sponsor ID
- SOPH-ACL-3+25
- Keywords
- ACL reconstruction, Quadriceps tendon graft, Semitendinosus graft, DKRR, Knee ligament injury, Orthopaedic surgery, Registry study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Abdirahman Hassan OmarUniversity, hospital or other
- Collaborators
- Søernes Privathospital
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Revision ACL reconstruction
- Multiligament knee reconstruction
- Missing or incomplete PROMs or key clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
3 secondary outcomes
Re-operation rate
Time frame: Within 1 year of surgery
Postoperative complications
Time frame: Within 1 year after surgery
Patient satisfaction
Time frame: 1 year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mikkel Attrup L MD, Orthopedic Surgeon contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Injury and Knee Injury, run by Abdirahman Hassan Omar at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdirahman Omar H Medical Students (+ 45 27 59 97 29, Namharidba2@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Knee Injury and Osteoarthritis Outcome Score (KOOS) (time frame: At minimum 1 year follow up postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.