NCT05329584

InSpace Accelerated Rehabilitation Study

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Stryker Endoscopy · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
DEVICE	InSpace Subacromial Tissue Spacer	Rotator Cuff Tear Treatment

Timeline

• Start date: 2022-02-07
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2022-04-15
• Last updated: 2025-05-29

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study