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InSpace Accelerated Rehabilitation Study — iAccelerate  

Rotator Cuff Tears Clinical Trial

Official title:
An Assessment of Two Accelerated Rehabilitation Programs for Use With the InSpaceTM Subacromial Tissue Spacer System in the Treatment of Full-thickness Massive, Irreparable Rotator Cuff Tears

Clinical Trial 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.

Clinical Trial Description

Study Objectives: Primary: • To evaluate clinical outcomes of both a formalized or an at-home rehabilitation program when used in conjunction with the InSpace device as compared to the corresponding InSpace Pivotal study results. - To demonstrate consistency of each intervention group with the corresponding historical control study results. - To demonstrate that comparable clinical outcomes can be achieved for each intervention group. Secondary: • Change in clinical outcomes compared to baseline. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05329584
Study type Interventional
Source Stryker Endoscopy
Contact Hayley Taylor, MS
Phone 805-705-4206
Email hayley.taylor@stryker.com
Status Recruiting
Phase N/A
Start date February 7, 2022
Completion date April 2025
View Details
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