A study to assess result after shoulder surgery

Phase 4

Conditions: Health Condition 1: M999- Biomechanical lesion, unspecified

Registration Number: CTRI/2023/07/055473

Lead Sponsor: Healthium Medtech Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Male and female subjects between 18 to 40 years of age.

2.Subjects with Bankarts lesion requiring primary Arthroscopic Bankarts repair surgery.

3.Subjects willing to give written informed consent to participate in the study.

Exclusion Criteria

1.Subjects with BMI =35 kg/m2.

2.Subjects with history of any surgery to the same shoulder.

3.Subjects with active infection or blood supply limitations.

4.Subjects with pathological conditions of bone or soft tissue that would impair secure fixation.

5.Subjects with known hypersensitivity to UHMWPE

6.Subjects with conditions, which would limit the subjects ability or willingness to restrict activities or follow directions during the healing period.

7.Subjects having any condition that could affect healing (eg. Infections, Regular use of Corticosteroids, Diabetes – HbA1C = 10).

8.Subjects with history of heavy smoking (= 20 cigarettes/day) within the last 6 months.

9.Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study

10.Subjects who are pregnant or lactating at the time of screening.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the shoulder function and stability post Bankarts repair using Knotted UHMWPE Suture AnchorTimepoint: Baseline, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 18 months post-surgery, and 24 months post-surgery

Secondary Outcome Measures

Name	Time	Method
1.To assess the functional outcomes post Bankarts repair using Knotted UHMWPE Suture Anchor <br/ ><br>2.To assess the instability after Bankart’s repair using Knotted UHMWPE Suture Anchor <br/ ><br>3.To assess the failure rate of Bankart’s repair using Knotted UHMWPE Suture Anchor <br/ ><br>4.To assess change in quality of life post Bankarts repair using Knotted UHMWPE Suture Anchor <br/ ><br>5.To assess the time to recovery post Bankarts repair using Knotted UHMWPE Suture Anchor <br/ ><br>6.To assess the overall intraoperative handling of Knotted UHMWPE Suture Anchor <br/ ><br>7.To evaluate the ligament and implant condition after Arthroscopic Bankarts repair surgery <br/ ><br>8.To assess the incidence of residual risks and safety of Knotted UHMWPE Suture AnchorTimepoint: Day of surgery, Day of Discharge, 15th day post-surgery, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 18 months post-surgery, and 24 months post-surgery