A study to assess success after knee surgery

Phase 4

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/04/051982
• Lead Sponsor: Dr Dhammapal Sahebrao Bhamare

Brief Summary

This study is a single-centre, retrospective, observational study to assess the safety and functional outcomes after arthroscopic meniscal repair using surestitch all inside meniscal repair implant. All patients who had undergone meniscus repair using Surestitch all inside meniscal repair implant between January 2019 to September 2022 will be included in the study.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-05
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients aged more than 18 years who has undergone meniscal repair surgery with Surestitch All-inside meniscal repair implant, between January 2019 to July 2022 2.
• Patients willing to provide verbal consent for the study during the telephonic follow-up visit.

Exclusion Criteria

• 1.Patients who have suffered from Traumatic injury to the same knee after meniscus repair surgery 2.
• Patients who cannot be contacted after 3 attempts.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the postoperative subjective knee function after meniscal repair using Surestitch implants	One followup after EC approval 6 months to 4.5 years after surgery

Secondary Outcome Measures

Name	Time	Method
1. To review the safety of Surestitch implants in meniscal repair by evaluating adverse events after surgery.	2. To compare the activity level in patients before and after meniscal repair.

Trial Locations

Locations (1)

Sainath Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Sainath Hospital

🇮🇳Pune, MAHARASHTRA, India

Dr Dhammapal Sahebrao Bhamare

Principal investigator

7507899338

drbhamareds@yahoo.co.in