Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

Not Applicable

Completed

• Conditions: Rupture of the Anterior Cruciate Ligament With Instability of the Knee Joint
• Interventions: Procedure: autograft tendon; Procedure: allograft tendon

• Registration Number: NCT00510848
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-02
• Status Verified: 2014-12
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	autograft tendon	Reconstruction with an autograft tendon (hamstrings)
2	allograft tendon	Reconstruction with an allograft tendon (tibialis posterior)

Primary Outcome Measures

Name	Time	Method
X-ray, CT-scan, KT1000	12 months

Secondary Outcome Measures

Name	Time	Method
X-rays, CT-scan, KT1000	24 months

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium