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Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00510848
First Posted: August 2, 2007
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
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.

Condition Intervention
Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint Procedure: autograft tendon Procedure: allograft tendon

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament: Randomized Clinical Trial With 2 Year Follow-up

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • X-ray, CT-scan, KT1000 [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • X-rays, CT-scan, KT1000 [ Time Frame: 24 months ]

Estimated Enrollment: 40
Study Start Date: August 2007
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Reconstruction with an autograft tendon (hamstrings)
Procedure: autograft tendon
Reconstruction with an autograft tendon (hamstrings)
Experimental: 2
Reconstruction with an allograft tendon (tibialis posterior)
Procedure: allograft tendon
Reconstruction with an allograft tendon (tibialis posterior)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510848


Contacts
Contact: Peter Verdonk, MD + 32 9 332.47.08 peter.verdonk@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Peter Verdonk, MD    + 32 9 332.47.08    peter.verdonk@ugent.be   
Principal Investigator: Peter Verdonk, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Peter Verdonk, MD University Hospital, Ghent
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00510848     History of Changes
Other Study ID Numbers: 2007/154
First Submitted: August 1, 2007
First Posted: August 2, 2007
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Rupture
Wounds and Injuries


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