A study to assess success after shoulder surgery
- Conditions
- Health Condition 1: M999- Biomechanical lesion, unspecified
- Registration Number
- CTRI/2023/05/052434
- 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
1.Male/ female participants between =30 years and = 70 of age at the time of consent
2.Participants with Rotator Cuff Tears requiring primary RCT repair
3.Participants/ Legally Acceptable Representative who are willing to provide written Informed Consent and comply with study procedures
1.Participants with evidence of osteoarthritis in the shoulder
2.Participants with evidence of infection, tumor or necrosis in the shoulder
3.Participants who had undergone previous surgery of the same shoulder
4.Participants having any contraindications for undergoing MRI
5.Participants with ? 9% HbA1c (Clinical laboratory reports up to 3 months will be considered valid otherwise participants will undergo blood investigation for HbA1C)
6.Participants with a history of deep vein thrombosis (DVT)
7.Participants who are smokers (smoking ? 20 cigarettes/day)
8.Participants with sensitivity to PEEK/ PLDLA-BTCP material
9.Participants with any condition which makes the subject unsuitable for study participation which as per the investigator would jeopardize the outcome of the trial or participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.
10.Pregnant and lactating female at the time of screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess overall functional outcomes in each cohort of Knotless PEEK Anchors with PEEK tip & Knotless PLDLA-B TCP Anchors with PEEK TipTimepoint: Time frame Screening/ Baseline, month 3, month 6, month 12, month 18 and month 24
- Secondary Outcome Measures
Name Time Method