A study to assess result after shoulder surgery
- Conditions
- Biomechanical lesion, unspecified,
- Registration Number
- CTRI/2023/07/055473
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Arthroscopic procedurestheoretically offer advantages of the decreased loss of motion, decreasedmorbidity, avoidance of subscapularis tenotomy, and the capacity to addressconcomitant intra-articular pathology, studies have shown a faster return to preoperativemuscle strength. StativKnotted UHMWPE Suture Anchor also referred as All suture anchor is made up ofNon-Absorbable Ultra-high-molecular-weight polyethylene (UHMWPE) braided suture,a fixation device intended to provide secure fixation of soft tissue to bone. However,there is limited information available on the performance outcome and safety ofthe product in the real time clinical setting. Therefore, there is a need forconducting prospective post-marketing study to obtain the data on productperformance outcome and clinical safety. The objective of the study is toevaluate the effectiveness and safety in patients who undergone arthroscopicBankarts Repair using Knotted UHMWPE Suture Anchor in 44 eligible subjects asper the study protocol.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 44
- 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.
- 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.
- 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 Anchor 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 2.To assess the instability after Bankart’s repair using Knotted UHMWPE Suture Anchor
Trial Locations
- Locations (8)
Apex Trauma Center, Sanjay Gandhi Post Graduate Institute of Medical Sciences
🇮🇳Lucknow, UTTAR PRADESH, India
Bangalore Medical College and Research Institute
🇮🇳Bangalore, KARNATAKA, India
Byramjee Jeejeebhoy Medical College
🇮🇳Ahmadabad, GUJARAT, India
Government Medical College, Thiruvananthapuram
🇮🇳Thiruvananthapuram, KERALA, India
KIMS-Kingsway Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Kumaran Hospitals and Rela Institute
🇮🇳Chennai, TAMIL NADU, India
New Civil Hospital
🇮🇳Surat, GUJARAT, India
VMMC and Safdarjung Hospital
🇮🇳Delhi, DELHI, India
Apex Trauma Center, Sanjay Gandhi Post Graduate Institute of Medical Sciences🇮🇳Lucknow, UTTAR PRADESH, IndiaDr Pulak SharmaPrincipal investigator8718043236drpulaksharma@gmail.com