Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

This study is currently recruiting participants.
Verified March 2014 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00510848
First received: August 1, 2007
Last updated: March 26, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • X-rays, CT-scan, KT1000 [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2007
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00510848     History of Changes
Other Study ID Numbers: 2007/154
Study First Received: August 1, 2007
Last Updated: March 26, 2014
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014