Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

Sponsor

University Hospital, Ghent (Other)

Overall Status

Unknown status

CT.gov ID

NCT00510848

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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	Phase
Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint	Procedure: autograft tendon Procedure: allograft tendon	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 1, 2007

Anticipated Primary Completion Date :

Jul 1, 2015

Anticipated Study Completion Date :

Jul 1, 2015

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)

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

X-ray, CT-scan, KT1000 [12 months]

Secondary Outcome Measures

X-rays, CT-scan, KT1000 [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent		Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator: Peter Verdonk, MD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT00510848

Other Study ID Numbers:

2007/154

First Posted:

Aug 2, 2007

Last Update Posted:

Dec 5, 2014

Last Verified:

Dec 1, 2014

Additional relevant MeSH terms:

Rupture

Study Results

No Results Posted as of Dec 5, 2014