Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

NCT ID: NCT00510848

Last Updated: 2022-12-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients suffering from a rupture of the anterior cruciate ligament (ACL) with instability of the knee joint are treated with an operative ACL-reconstruction: one group of patients with a reconstruction with an autograft tendon (hamstrings), the other group with a reconstruction with an allograft tendon (tibialis posterior). The same surgical technique, the same fixation technique and the same rehabilitation protocol will be used in both groups. Follow-up will be done during 2 years.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Reconstruction with an autograft tendon (hamstrings)

Group Type EXPERIMENTAL

autograft tendon

Intervention Type PROCEDURE

Reconstruction with an autograft tendon (hamstrings)

2

Reconstruction with an allograft tendon (tibialis posterior)

Group Type EXPERIMENTAL

allograft tendon

Intervention Type PROCEDURE

Reconstruction with an allograft tendon (tibialis posterior)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

autograft tendon

Reconstruction with an autograft tendon (hamstrings)

Intervention Type PROCEDURE

allograft tendon

Reconstruction with an allograft tendon (tibialis posterior)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* isolated rupture of the anterior cruciate ligament with instability of the knee joint
* meniscal tear possible to suture
* partial meniscectomies

Exclusion Criteria

* chronic laxity (more than 9 months)
* associated collateral laxity (grade III)
* subtotal or total meniscectomy
* infection or inflammatory disease of the knee joint
* large cartilage lesion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Peter Verdonk, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

Robbrecht C, Claes S, Cromheecke M, Mahieu P, Kakavelakis K, Victor J, Bellemans J, Verdonk P. Reliability of a semi-automated 3D-CT measuring method for tunnel diameters after anterior cruciate ligament reconstruction: A comparison between soft-tissue single-bundle allograft vs. autograft. Knee. 2014 Oct;21(5):926-31. doi: 10.1016/j.knee.2014.05.003. Epub 2014 May 20.

Reference Type DERIVED
PMID: 25022839 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007/154

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of Meniscal Allografts
NCT01059409 TERMINATED NA
ACL Versus ALL + ACL Study
NCT03740022 COMPLETED NA