A study to assess result after shoulder surgery

Phase 4

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

Registration Number: CTRI/2023/04/052027

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 30 to 70 years of age.

2.Subjects with rotator cuff tear requiring primary arthroscopic rotator cuff tear repair surgery.

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

Exclusion Criteria

1.Subjects with BMI =35 kg/m2

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

3.Subjects with active infection or blood supply limitations.

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

5.Subjects with known hypersensitivity to titanium or UHMWPE.

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

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

8.Subjects with a 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 evaluate the functional outcomes of the shoulder after Arthroscopic Rotator Cuff Tears Repair from baseline to 24 months post-surgery.Timepoint: 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