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Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

Primary Purpose

Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
autograft tendon
allograft tendon
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Reconstruction with an autograft tendon (hamstrings)

Reconstruction with an allograft tendon (tibialis posterior)

Outcomes

Primary Outcome Measures

X-ray, CT-scan, KT1000

Secondary Outcome Measures

X-rays, CT-scan, KT1000

Full Information

First Posted
August 1, 2007
Last Updated
November 29, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00510848
Brief Title
Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament
Official Title
Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament: Randomized Clinical Trial With 2 Year Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2007 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Reconstruction with an autograft tendon (hamstrings)
Arm Title
2
Arm Type
Experimental
Arm Description
Reconstruction with an allograft tendon (tibialis posterior)
Intervention Type
Procedure
Intervention Name(s)
autograft tendon
Intervention Description
Reconstruction with an autograft tendon (hamstrings)
Intervention Type
Procedure
Intervention Name(s)
allograft tendon
Intervention Description
Reconstruction with an allograft tendon (tibialis posterior)
Primary Outcome Measure Information:
Title
X-ray, CT-scan, KT1000
Time Frame
12 months
Secondary Outcome Measure Information:
Title
X-rays, CT-scan, KT1000
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Verdonk, MD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
25022839
Citation
Robbrecht C, Claes S, Cromheecke M, Mahieu P, Kakavelakis K, Victor J, Bellemans J, Verdonk P. Reliability of a semi-automated 3D-CT measuring method for tunnel diameters after anterior cruciate ligament reconstruction: A comparison between soft-tissue single-bundle allograft vs. autograft. Knee. 2014 Oct;21(5):926-31. doi: 10.1016/j.knee.2014.05.003. Epub 2014 May 20.
Results Reference
derived

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Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

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