Study of shoulder joint treatment

Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of AUXILOCK Shoulder Arthroscopy System - Nil

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/07/069812

Enrollment

Registered

2024-07-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S460- Injury of muscle(s) and tendon(s)of the rotator cuff of shoulder

Interventions

Intervention1: Shoulder arthroscopy implants: Study participants will be followed at 6 week, 3 month, 6 month and 12 month. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: ? Subject is willing and able to give Written informed consent for participation. ? No history of surgery on affected Shoulder. ? Male or Female, aged between 18 to 75 years. ? Subject scheduled for Shoulder arthroscopic surgery for fixation of Shoulder related ligaments and tendons repair.

Exclusion criteria

Exclusion criteria: ? Subject having any local active infections, blood supply limitations, diseases or other systemic conditions that may retard healing or create unacceptable risk of fixation failure. ? Subject having inadequate tissue coverage on the operative site, where suture anchor performances would be compromised. ? Subject having foreign body sensitivities where precautionary or mitigation methods are inadequate to control the conditions. ? Subjects with substance abuse/alcohol issues. ? Subjects who are incarcerated or have pending incarceration. ? Subjects with mental disorders ? Subject who has contraindication mentioned in the IFU. ? Female participant who is pregnant or planning pregnancy during the course of the clinical study. ? Subjects inability or unwillingness to follow surgeon’s prescribed post-operative care after shoulder arthroscopy surgery.

Design outcomes

Primary

Measure	Time frame
1. Time taken to achieve full weight lifting capacity. 2. Evaluation of functional scores; ASES and WOSI following the arthroscopic surgery.Timepoint: 6 weeks, 3, 6, 12 months	—

Secondary

Measure	Time frame
1. Evaluation of shoulder pain by VAS following arthroscopic surgery. 2. Assessment of device related of AE, and SAEs.Timepoint: 6 weeks, 3, 6, 12 months	—

Countries

India

Contacts

Public ContactDr Mohd Aslam

Auxein Medical Pvt Ltd

clinical2@auxeinmedical.com7419660141

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026