Completed PHASE4 INTERVENTIONAL 2-arm NCT00208338

Pilot Study to Evaluate the Restore Orthobiologic Implant in Rotator Cuff Tear Repair

A Prospective, Randomised Pilot Study to Determine the Variability of Early Clinical Outcome in Subjects Undergoing Full Thickness Rotator Cuff Tear Repair, When Augmented With or Without Porcine Small Intestine Submucosa (RESTORE)

Sponsor: DePuy International

Conditions Arm Injuries

Interventions RESTORE SIS Patch Rotator cuff repair

Updated 6 times since 2017 Last updated: Jul 1, 2016 Started: Jul 31, 2005 Primary completion: Feb 28, 2007 Completion: Apr 30, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Arm Injuries and is currently completed. DePuy International leads this study, which shows 6 recorded versions since 2005 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2021 — Jul 2024 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4
Feb 2017 — Jun 2018 [monthly]

Completed PHASE4

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE4

First recorded

Jul 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

DePuy International

Data source: DePuy International

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Leuven, Belgium
• Liverpool, United Kingdom