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Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

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ClinicalTrials.gov Identifier: NCT00510848
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : August 2, 2007
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint Procedure: autograft tendon Procedure: allograft tendon

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : August 2007
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

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

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

Eligibility Criteria

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 Posted: August 2, 2007    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Rupture
Wounds and Injuries