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Evaluate the Rotator Cuff Repair With "InSpace" VS Without "InSpace"

NCT04704700 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-05

No results posted yet for this study

Summary

Evaluate the re-rupture rate 12 months following the intervention in a group with and a group without a spacer

Conditions

  • Repair of a Cuff Tear

Interventions

DEVICE

repair of a cuff tear

Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon

DEVICE

repair of a cuff tear

Group (Control): standard Arthroscopic repair of the cuff rotator

Sponsors & Collaborators

  • Clinique Bizet

    lead OTHER

Principal Investigators

  • philippe VALENTI, DOCTOR · Clinique Bizet

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04704700 on ClinicalTrials.gov