Health Condition 1: M668- Spontaneous rupture of other tendons
Conditions
Interventions
Intervention1: Clinifibre® Suture: Clinifibre® (Healthium) is a sterile synthetic multifilament braided non-absorbable surgical suture prepared from fibers of ultra-high molecular weight polyethylene.
Sponsors
Healthium Medtech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Subject with body mass index 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To evaluate the clinical outcomes, objective functional outcomes, patient-reported functional outcomes, and patient-related quality of life between two groups 2.To assess the intra- and post-operative complications and to assess overall intraoperative handling between two sutures 3.To evaluate the return to activity, post operatively 4.To evaluate tissue reaction, material problems and other adverse eventsTimepoint: Pre-Surgery: Screening visit, Enrolment/Surgery visit (day 0, Baseline Visit 1) 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) | — |
Countries
India
Contacts
Public ContactDr Ashok Kumar Moharana
Healthium Medtech Limited
Outcome results
None listed