A study comparing two suture materials for graft preparation in knee ligament surgery
- Conditions
- Health Condition 1: M668- Spontaneous rupture of other tendons
- Registration Number
- CTRI/2021/09/036704
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Skeletally mature subjects of both gender aged 18-50 years undergoing Unilateral Primary ACL Reconstruction
2. Subjects requiring ultra-high-molecular-weight polyethylene (UHMWPE) suture for hamstring autograft preparation
3. Subject having contralateral healthy knee on clinical examination
4. Subject with physical activity classified by Tegner scale = 1
5. Subject who has given written informed consent
1. Subject with body mass index <18.5 or >30 kg/m2
2. Subject undergoing ACL reconstruction using bone-patellar tendon-bone graft
3. Subject who is a professional athlete
4. Subject with HbA1c more than 10
5. Subject who is a heavy smoker i.e., smoking = 20 cigarettes per day
6. Subject having posterior crutiate ligament injury, or other collateral ligament injury
7. Subject having obvious change in the alignment of the mechanical axis requiring surgical correction (Varus or Valgus malalignment greater than 3 degrees)
8. Subject having generalized ligamentous laxity (Beighton score of 4 or greater or defined as the simultaneous presence of joint hypermobility at the four limbs and axial skeleton, with involvement of both the major and minor joints)
9. Subject with history of bleeding disorder, connective tissue disorder or congenital disease that predispose a patient for articular cartilage damage
10. Subject not achieving 90° of flexion in the affected knee before surgery.
11. Subject having osseous fractures or trauma that could impair rehabilitation and/or ACL repair.
12. Subject who is pregnant
13. Subject with history of allergy to polyethylene or similar products
14. Subject who is already participating in another trial or have received an experimental drug or have used an experimental medical device within 30 days prior to the planned start of procedure
15. Subject unlikely to comply with surgical procedure, rehabilitation protocol or complete the scheduled follow up visit, in the opinion of investigator
16. Employee of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
17. Other indication-based exclusion, in opinion of investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the incidence of residual risks of sutures (including infection, suture breakage, allergy and inflammatory reaction) in both the groups within 52 weeks after surgeryTimepoint: Pre-Surgery: Screening visit, Enrolment/Surgery visit (day 0, Baseline Visit 1) <br/ ><br> <br/ ><br>Post-operative: Day of Discharge (Visit 2), Week 1-3 (Visit 3), Week 6-12 ( Visit 4), Week 26 (Telephonic Visit 5), Week 52 (Visit 6) <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.To evaluate the clinical outcomes, objective functional outcomes, patient-reported functional outcomes, and patient-related quality of life between two groups <br/ ><br>2.To assess the intra- and post-operative complications and to assess overall intraoperative handling between two sutures <br/ ><br>3.To evaluate the return to activity, post operatively <br/ ><br>4.To evaluate tissue reaction, material problems and other adverse eventsTimepoint: Pre-Surgery: Screening visit, Enrolment/Surgery visit (day 0, Baseline Visit 1) <br/ ><br> <br/ ><br>Post-operative: Day of Discharge (Visit 2), Week 1-3 (Visit 3), Week 6-12 ( Visit 4), Week 26 (Telephonic Visit 5), Week 52 (Visit 6)