Health Condition 1: S429- Fracture of shoulder girdle, partunspecified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.The Subjects who are eligible for the arthroscopy system, which is used in the surgical procedures related to shoulder ligament fracture fixation, are included in the study. 2.Arthroscopy Shoulder System implants are intended to be used in both men and non-pregnant women of age 18 years or above. 3.The Subjects who require connective tissue tendon repairs for elbow, hand/wrist, and shoulder. 4.Subjects who require general soft tissue approximation and/or ligation, including orthopedic procedures, are included in the study. 5.The Subject must be willing and able to provide written Informed Consent by signing and dating the IRB or EC approved Informed Consent form. If the Subject is not able to write on behalf of the Subject, the Subject`s Legally acceptable representative (LAR) can fill out the informed consent. When a Subject and LAR are illiterate, a literate impartial witness is required during consenting.
Exclusion criteria
Exclusion criteria: 1.Systemic or acute or chronic infection at the surgical site. 2.Known allergy or sensitivity to product materials. 3.Insufficient tissue coverage in the surgical area. 4.A subject who is unwilling or unsuitable for postoperative instructions. 5.Pregnant women are excluded from the study. 6.Any medical or surgical condition that would preclude the potential benefit of the operation. 7.Fever or leukocytosis. 8.Any medical or surgical condition that could affect the potential benefit of the operation. 9.The Subject who is unwilling or unable to sign the Informed Consent Document will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Implant failure rate 2.Reoperation rate 3.Intra-operative ComplicationsTimepoint: 1.Time Frame: Intra-operative, 3 weeks 10 days, 3 months 15 days, 6 months 15 days, 1 year 30 days, 2 years 30 days 2.Time Frame: 3 weeks 10 days, 3 months 15 days, 6 months 15 days, 1 year 30 days, 2 years 30 days 3.Time Frame: Intraoperative | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Implant failure rate 2.Sugaya Score 3.Reoperation rate 4.Constant-Murley score 5.Wound Complications 6.Visual Analog Scale Pain Score 7.Range of Motion 8.Length of Hospital Stay 9.SF-12 Questionnaire 10.Radiographic Analysis 11.Adverse Events related to the deviceTimepoint: 1.Time Frame: 3 years 30 days, 4 years 30 days, 5 years 30 days 2.Time Frame: 6 months 15 days 3.Time Frame: 3 years 30 days, 4 years 30 days, 5 years 30 days 4.Time Frame: Pre-operative, 3 weeks 10 days, 3 months 15 days, 6 months 15 days, 1 year 30 days, 2 years 30 days, 3 years 30 days, 4 years 30 days, 5 years 30 days 5.Time Frame: Discharge, 3 weeks 10 days, 3 months 15 days, 6 months 15 days, 1 year 30 days, 2 years 30 days, 3 years 30 days, 4 years 30 days, 5 years 30 days 6. Time Frame: Preoperative, 3 weeks 10 days, 3 months 15 days, 6 months 15 days, 1 year 30 days, 2 years 30 days, 3 years 30 days, 4 years 30 days, 5 years 30 days 7.Time Frame: Pre-operative, 3 weeks 10 days, 3 months 15 days, 6 months 15 days, 1 year 30 days, 2 years 30 days, 3 years 30 days, 4 years 30 days, 5 years 30 days 8.Time Frame: Admission to discharge 9.Time Frame: Pre-operative, 3 weeks 10 days, 3 months 15 days, 6 months 15 days, 1 year 30 days, 2 years 30 days, 3 years 30 days,4 years 30 days, 5 years 30 days 10.Time Frame: Preoperative, 6 months 15 days 11.Time Frame: Discharge, 3 weeks 10 days, 3 months 15 days, 6 months 15 days, 1 year 30 days, 2 years 30 days, 3 years 30 days, 4 years 30 days, 5 years 30 days | — |
Countries
India
Contacts
Public ContactDr Kirankumar Shetty
Meril Life Sciences Pvt. Ltd
Outcome results
None listed