CTRI/2025/07/091413 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On:
11/12/2025
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Medical Device
Study Design
Single Arm Study
Public Title of Study
Arthroscopy Implants for Shoulder
Scientific Title of Study
A Prospective, Multi-centre, Single-arm, Open-label, Post market clinical follow-up study to Evaluate Safety and Performance of the Arthroscopy Implants for Shoulder In a Real-World Setting.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
MHCPL/Arthroscopy Implants V 1.0.0 dated 12 Sept 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Kirankumar Shetty
Designation
DGM - Product Performance & Engineering Department
Affiliation
Meril Life Sciences Pvt. Ltd
Address
Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India Valsad
Valsad GUJARAT 396191 India
Phone
9743700109
Fax
Email
kirankumar.shetty@merillife.com
Details of Contact Person Scientific Query
Name
Dr Kirankumar Shetty
Designation
DGM - Product Performance & Engineering Department
Affiliation
Meril Life Sciences Pvt. Ltd
Address
Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India Valsad
GUJARAT 396191 India
Phone
9743700109
Fax
Email
kirankumar.shetty@merillife.com
Details of Contact Person Public Query
Name
Dr Kirankumar Shetty
Designation
DGM - Product Performance & Engineering Department
Affiliation
Meril Life Sciences Pvt. Ltd
Address
Buiding number 6, 3rd floor, Near Bilakhia Stadium, Survey no 135,139,Muktanand marg, Chala, Vapi-396191, Gujarat, India Valsad
GUJARAT 396191 India
Phone
9743700109
Fax
Email
kirankumar.shetty@merillife.com
Source of Monetary or Material Support
Meril Healthcare Pvt. Ltd.
Meril Park, H1-H3,
Survey No. 1575 and 1088,
Muktanand Marg, Chala, Vapi,
Valsad, Gujarat– 396191
Primary Sponsor
Name
Meril Life Sciences Pvt Ltd
Address
Near Bilakhia Stadium, Survey no 135/139,Muktanand marg, Chala, Vapi-396191, Gujarat, India
(1) ICD-10 Condition: S429||Fracture of shoulder girdle, partunspecified,
Intervention / Comparator Agent
Type
Name
Details
Intervention
NIL
NIL
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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.
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 Outcome
Outcome
TimePoints
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 device
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
Target Sample Size
Total Sample Size="110" Sample Size from India="110" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Post Marketing Surveillance
Date of First Enrollment (India)
21/08/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="5" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Study Name: A Prospective, Observational, Multi-centre, Single-arm, Openlabel, Post-market Clinical Follow-up Study to Evaluate Safety
and Performance of the Arthroscopy Implants for Shoulder in a
Real-World Setting.
Short Title: Arthroscopy ImplantsFor Shoulder
Protocol ID, Version and Date: MHCPL/Arthroscopy Implants for Shoulder_Version 1.0.0_12-
Sep-2024
Study Device: Arthroscopy Implants for Shoulder
Indication: 1.Arthroscopy implants for the shoulder: These are
indicated in all connective tissue tendon repairs together
with the indications for shoulder-bankart lesion, rotator
cuff rupture, slap lesion, acromioclavicular separation,
biceps tenodesis, deltoid tear/separation, capsular shift,
capsulolabral reconstruction, biceps tendon separation,
ulnar and radial collateral ligament rupture/separation,
scapholunate ligament tear/separation, and ulnar or
radial collateral ligament. 2. Suture: Indicated in general soft tissue approximation,
and/or ligation, including orthopedic procedures.
Objective: The study aims to evaluate the safety and performance of
arthroscopy implants for the shoulder in subjects who require
arthroscopy implantation in a real-world setting.
Study Design: A Prospective, Observational, Multi-centre, Single-arm, Open label, Post-market Clinical Follow-up Study.
Rationale of the Study
Arthroscopy implants have become essential tools in minimally invasive orthopedic procedures,
particularly for treating conditions in the shoulder, elbow, and hand/wrist joints. These
procedures allow for targeted interventions, offering Subjects faster recovery times, less postoperative pain, and improved mobility compared to traditional open surgeries. However, there
remains a need to comprehensively assess the safety and performance of these implants in realworld settings, where subject populations may vary significantly from clinical trials.This study is
designed to evaluate the safety profile and performance of arthroscopy implants in diverse
subject populations undergoing shoulder, elbow, and hand/wrist surgeries.