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

Arm Injuries Clinical Trial

Official title: 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)

Status Completed

Clinical Trial Summary

Primary Endpoints:

Comparative evaluation of any differences between the two groups in change from baseline to the 3-month time point in terms of:

• Functional recovery (patient-based) - using the Oxford Shoulder Score.

• Functional recovery and early return of strength (pain, activities of daily living [ADL], range of motion [ROM], and power) - evaluated using the Constant Shoulder Assessment.

• Functional recovery (pain and function - patient-based), evaluated using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment - patient self-report section.

• Region-specific Quality of Life - using the Western Ontario Rotator Cuff (WORC) Index.

• Range of motion - assessed by goniometer recorded as part of the Constant Score.

• Pain (taken from Pain visual analog scale [VAS] of the ASES Shoulder Assessment); and

• Record of escape pain medication usage (recorded in a daily patient diary).

Secondary Endpoints:

Comparative evaluation of any difference between the two groups in change from baseline to the 6-week time point, in terms of:

• Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain medication usage (recorded in a daily patient diary).

Comparative evaluation of any differences between the two groups in change from baseline to the 6-month time point, in terms of:

• Functional recovery (patient-based) - using the Oxford Shoulder Score.

• Functional recovery and early return of strength (pain, ADL, ROM, and power) - evaluated using the Constant Shoulder Assessment.

• Functional recovery (pain and function - patient-based), evaluated using the ASES Shoulder Assessment - patient self-report section.

• Region-specific Quality of Life - using the Western Ontario Rotator Cuff Index.

• Range of motion - assessed by goniometer recorded as part of the Constant Score.

• Pain (taken from Pain VAS of the ASES Shoulder Assessment) and record of escape pain medication usage (recorded in a patient diary).

Comparative evaluation of any difference between the two groups in change from baseline to the 6-week, 3, 6 and 12 month time points, in terms of health status - assessed by the EQ-5D instrument.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arm Injuries

• NCT number: NCT00208338
• Study type: Interventional
• Source: DePuy International
• Status: Completed
• Phase: Phase 4
• Start date: July 2005
• Completion date: April 2015