Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014