Clinical Trials Logo
  1. Home
  2. Rotator Cuff Tears
  3. NCT05329584

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
See also
  Status Clinical Trial Phase
Recruiting NCT04974242 - Physiotherapy for Patients Awaiting Rotator Cuff Repair N/A
Recruiting NCT06055478 - Effect of Suprascapular Nerve Block and Axillary Nerve Block After Arthroscopic Rotator Cuff Repair N/A
Completed NCT04552925 - Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears N/A
Not yet recruiting NCT06032416 - DenCT Shoulder Bone Quality Evaluation N/A
Not yet recruiting NCT04047745 - Post-operative Exparel Study Following Rotator Cuff Repair N/A
Completed NCT01029574 - Platelet Rich Plasma on Rotator Cuff Repair Phase 3
Not yet recruiting NCT05817578 - Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm
Not yet recruiting NCT05670080 - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? N/A
Suspended NCT04421417 - The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing N/A
Recruiting NCT06156423 - Investigation of the Effect of Motor Control Exercises in Patients Undergoing Rotator Cuff Surgery N/A
Completed NCT06145815 - Machine Learning Predictive Model for Rotator Cuff Repair Failure
Not yet recruiting NCT05009498 - Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery N/A
Terminated NCT04855968 - The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption N/A
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Not yet recruiting NCT04538001 - Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear N/A
Completed NCT04710966 - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears N/A
Recruiting NCT06192459 - Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear N/A
Recruiting NCT05925881 - Lower Trapezius Transfer vs Bridging Reconstruction N/A
Recruiting NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. N/A
Not yet recruiting NCT04587037 - A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear N/A