- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00510848
Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament
November 29, 2022 updated by: University Hospital, Ghent
Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament: Randomized Clinical Trial With 2 Year Follow-up
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ghent, Belgium, 9000
- University Hospital Ghent
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Reconstruction with an autograft tendon (hamstrings)
|
Reconstruction with an autograft tendon (hamstrings)
|
Experimental: 2
Reconstruction with an allograft tendon (tibialis posterior)
|
Reconstruction with an allograft tendon (tibialis posterior)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
X-ray, CT-scan, KT1000
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
X-rays, CT-scan, KT1000
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Verdonk, MD, University Hospital, Ghent
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2007
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
August 1, 2007
First Submitted That Met QC Criteria
August 1, 2007
First Posted (Estimate)
August 2, 2007
Study Record Updates
Last Update Posted (Actual)
December 2, 2022
Last Update Submitted That Met QC Criteria
November 29, 2022
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007/154
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint
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University Hospital, GhentCompletedRupture of the Anterior Cruciate Ligament With Instability of the Knee JointBelgium
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University of CalgaryWorkers' Compensation Board, AlbertaActive, not recruitingAnterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Injury | Chronic Instability of Knee | Deficiency of Anterior Cruciate LigamentCanada
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Medical University of GrazCompleted
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Children's Hospital ColoradoSmith & Nephew, Inc.RecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament Tear | Arthrofibrosis of KneeUnited States
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University of VirginiaUniversity of KentuckyUnknownComplete Tear, Knee, Anterior Cruciate Ligament | Rupture of Anterior Cruciate LigamentUnited States
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Indonesia UniversityUnknownAnterior Cruciate Ligament Rupture | Cartilage Damage | Knee InstabilityIndonesia
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Aarhus University HospitalCompletedRupture of Anterior Cruciate Ligament | Ligament; Laxity, KneeDenmark
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Soft Tissue Regeneration, Inc.TerminatedAcute Ruptures of the Anterior Cruciate LigamentNetherlands
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National Police HospitalCompletedRupture of Anterior Cruciate Ligament | Rupture of Posterior Cruciate LigamentKorea, Republic of
Clinical Trials on autograft tendon
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Orthopedisch Centrum Oost NederlandMartini Hospital Groningen; Gelderse Vallei HospitalRecruitingAnterior Cruciate Ligament InjuriesNetherlands
-
McMaster UniversityCanadian Orthopaedic Foundation; The Physicians' Services Incorporated FoundationRecruitingACL - Anterior Cruciate Ligament RuptureCanada
-
Indonesia UniversityCompletedAnterior Cruciate Ligament Injuries | Ligament; Rupture, Knee, Spontaneous | Tendon Graft; Complication, Mechanical
-
Artromedical Konrad Malinowski ClinicRecruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | Anterior Cruciate Ligament TearPoland
-
Tanta UniversityCompletedSurgical Procedure, Unspecified | Ocular Discomfort | Strabismus, Divergent
-
Ain Shams UniversityActive, not recruiting
-
Brian WaltersCompletedPost Operative PainUnited States
-
Ankara City Hospital BilkentAtaturk University; Kutahya Health Sciences University; Fatih Sultan Mehmet Training... and other collaboratorsRecruitingAnterior Cruciate Ligament RuptureTurkey
-
Universidad de GranadaCompletedAcute Injury of Anterior Cruciate LigamentSpain