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OpenTrials
Completed

NCT Number: NCT00510848

Hamstrings Autograft Versus Tibialis Allograft for Reconstruction of Anterior Cruciate Ligament

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autograft tendon

Procedure

Reconstruction with an autograft tendon (hamstrings)

allograft tendon

Procedure

Reconstruction with an allograft tendon (tibialis posterior)

Primary outcomes

  1. X-ray, CT-scan, KT1000

    Time frame: 12 months

Secondary outcomes

  1. X-rays, CT-scan, KT1000

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Aug 2, 2007
Registry last updated
Dec 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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