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

NCT00208338 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2016-07-04

No results posted yet for this study

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.

Conditions

  • Arm Injuries

Interventions

DEVICE

RESTORE SIS Patch

Surgical repair of torn rotator cuff with RESTORE Porcine Small Intestine Submucosa patch (RESTORE SIS Patch) reinforcement

PROCEDURE

Rotator cuff repair

Standard surgical repair of torn rotator cuff

Sponsors & Collaborators

  • DePuy International

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-02-28
Completion
2015-04-30

Countries

  • Belgium
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00208338 on ClinicalTrials.gov