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A Pivotal Study to Assess the InSpace™ Device for Treatment of Full Thickness Massive Rotator Cuff Tears

NCT02493660 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2022-06-15

Study results available
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Summary

A pivotal study to assess the safety and effectiveness of the InSpace™ device implantation in comparison to surgical partial repair of full thickness Massive Rotator Cuff Tear (MRCT).

Conditions

  • Rotator Cuff Syndrome

Interventions

DEVICE

InSpace sub-acromial tissue spacer system

Arthroscopic implantation of InSpace sub-acromial tissue spacer system

PROCEDURE

Partial repair of rotator cuff

Arthroscopic partial repair of rotator cuff

Sponsors & Collaborators

  • OrthoSpace Ltd.

    lead INDUSTRY

Principal Investigators

  • Assaf Dekel, MD · Ortho-Space

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-26
Primary Completion
2020-02-29
Completion
2020-03-17

Countries

  • United States
  • Canada

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 NCT02493660 on ClinicalTrials.gov