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InSpace™ System in Comparison to Best Repair of Massive Rotator Cuff Tear

NCT02211183 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-04-06

No results posted yet for this study

Summary

This is a post-marketing study to further assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical repair of full thickness Massive Rotator Cuff Tear .

Conditions

  • Rotator Cuff Tear

Interventions

PROCEDURE

Best Repair of torn Rotator Cuff

DEVICE

InSpace™ system

Sponsors & Collaborators

  • OrthoSpace Ltd.

    lead INDUSTRY

Principal Investigators

  • Emilio Calvo, MD · Head of Shoulder and Elbow Reconstructive Surgery Unit, Department of Orthopedic Surgery and Traumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-01-31
Completion
2016-02-29

Countries

  • Spain

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 NCT02211183 on ClinicalTrials.gov