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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00208338
First received: September 13, 2005
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Arm Injuries
 Device: RESTORE SIS Patch
Procedure: Rotator cuff repair
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Difference demonstrated between two groups on the Oxford Shoulder Score from baseline to 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Difference demonstrated between two groups on the Constant Shoulder Assessment from baseline to 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Difference demonstrated between two groups on the ASES Shoulder Assessment from baseline to 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Difference demonstrated between two groups on the Western Ontario Rotator Cuff Index from baseline to 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Difference demonstrated between 2 groups on EQ-5D from baseline to 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Difference demonstrated between the two groups on the Constant Shoulder Assessment from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Difference demonstrated between the two groups on the Oxford Shoulder Score from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Difference demonstrated between the two groups on the Western Ontario Rotator Cuff from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Difference demonstrated between 2 groups on EQ-5D from baseline to 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Difference demonstrated between 2 groups on EQ-5D from baseline to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Difference demonstrated between 2 groups on EQ-5D from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: June 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rotator cuff repair with RESTORE Porcine Small Intestine Submucosa patch reinforcement
 Device: RESTORE SIS Patch
Surgical repair of torn rotator cuff with RESTORE Porcine Small Intestine Submucosa patch reinforcement
Active Comparator: 2
Standard rotator cuff repair
 Procedure: Rotator cuff repair
Standard surgical repair of torn rotator cuff

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subjects, aged 40 and above.
  • Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
  • Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the hospital for all the required post-operative follow-ups.
  • Subjects whose clinical symptoms and diagnosis suggest that they have a full-thickness rotator cuff tear (which includes but is not limited to the supraspinatus), which is degenerate in nature.

Exclusion Criteria:

  • Subjects who, in the opinion of the Investigator, have an existing condition that would prevent them from fulfilling the requirements of the Clinical Investigation Plan. (This should be detailed in the Screening Log.)
  • Women who are pregnant.
  • Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
  • Subjects who have participated in a clinical study with an investigational product in the last 6 months.
  • Subjects who are currently known to be involved in any injury litigation claims relating to the shoulder being treated as part of the study.
  • Subjects with a known allergy to porcine material or who, for religious or other reasons, are unwilling to accept a porcine-derived implant.
  • Subjects who have undergone previous shoulder surgery (excluding purely-diagnostic arthroscopy).
  • Subjects with significant paralysis of the shoulder.
  • Subjects with inflammatory arthropathies.
  • Subjects with active joint or systemic infection.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00208338

Locations
Belgium
U.Z. Gasthuis Berg
Leuven, Belgium, B-3000
United Kingdom
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Sponsors and Collaborators
DePuy International
Investigators
Principal Investigator: Prof Simon Frostick Royal University Hospital Liverpool
  More Information

No publications provided

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00208338     History of Changes
Other Study ID Numbers: CT 04/17
Study First Received: September 13, 2005
Last Updated: April 4, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Institutional Review Board

Keywords provided by DePuy International:
Rotator cuff tear repair

Additional relevant MeSH terms:
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013