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InSpace Accelerated Rehabilitation Study

NCT05329584 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-05-29

No results posted yet for this study

Summary

This is a prospective, parallel group, open-label, multi- center, randomized study to assess two accelerated rehabilitation programs for use with the InSpace device in the treatment of full thickness Massive, Irreparable Rotator Cuff Tears (MIRCTs) performed during an arthroscopic procedure.

Conditions

  • Rotator Cuff Tears

Interventions

DEVICE

InSpace Subacromial Tissue Spacer

Rotator Cuff Tear Treatment

Sponsors & Collaborators

  • Stryker Endoscopy

    lead INDUSTRY

Principal Investigators

  • Colleen Roden, MS · Stryker Endoscopy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2026-04-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

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 NCT05329584 on ClinicalTrials.gov