Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

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

Official title:

Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament: Randomized Clinical Trial With 2 Year Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510848
• Other study ID #: 2007/154
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: July 2015

Study information

• Verified date: December 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• autograft tendon
Reconstruction with an autograft tendon (hamstrings)
• allograft tendon
Reconstruction with an allograft tendon (tibialis posterior)

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	X-ray, CT-scan, KT1000		12 months
Secondary	X-rays, CT-scan, KT1000		24 months