A study comparing two grafts for treatment of knee instability
- Conditions
- Anterior cruciate ligament injury/insuffieciency/tear
- Registration Number
- CTRI/2017/03/008098
- Lead Sponsor
- Jawaharlal institute of postgraduate medical education and research puducherry
- Brief Summary
This study is a randomized, double blind, parallel group, trail comparing the safety and efficacy of quadriceps tendon autograft and Hamstrings tendons autograft for anterior cruciate ligamnent insuffieciency. The study will be conducted at Jawaharlal institute of postgraduate medical education and research puducherry on 60 patients meeting the inclusion and exclusion criteria. The primary outcome measures will be measurement of one leg hop index at the end of one year after the anterior cruciate ligament reconsctrution with either of the grafts. The secondary outcomes will be measurement of international knee documentation committee (IKDC) subjective and objective assessments at the end of one.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
patients with complete/partial ACL rupture with or without concomitant grade I and Grade II injuries to the collateral ligaments requiring surgery due to instability.
- 1 Patients presenting with an ACL injury greater than one year will be excluded from the study.
- 2 Patients with avulsion fractures will be excluded from the study.
- 3 Inability to give informed consent for the study.
- 5 Current or past injuries to the ipsi- or contralateral knee, possibly altering knee function, including previous ACL rupture.
- 6 Patients with a concomitant posterior cruciate ligament injury 7 Concomitant articular cartilage lesions larger than 2 cm with a depth of more than 50%of the cartilage thickness; and meniscal injuries involving more than two-thirds of the meniscus or the need for meniscus repair.
- 8 Mal-alignment of the lower extremity (greater than 5 mm of mechanical axis deviation as measured on standing hip-knee-ankle radiographs).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method measurement of the one leg hop index after quadriceps tendon(QT) autograft and hamstrings tendon autograft for ACLR at the end of one year. one year after operation.
- Secondary Outcome Measures
Name Time Method measurement of the functional outcomes using subjective international knee documentation committee( IKDC) form. one year after operation
Trial Locations
- Locations (1)
jawaharlal institute of postgraduate medical education and research
🇮🇳Pondicherry, PONDICHERRY, India
jawaharlal institute of postgraduate medical education and research🇮🇳Pondicherry, PONDICHERRY, IndiaDr sandeep kumar nemaPrincipal investigatordrsandeepnema@gmail.com