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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Smal

Brief 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:

    Detailed Summary:
    Sponsor: DePuy International

    Current Primary Outcome:

    • Difference demonstrated between two groups on the Oxford Shoulder Score from baseline to 3 months [ Time Frame: 3 months ]
    • Difference demonstrated between two groups on the Constant Shoulder Assessment from baseline to 3 months [ Time Frame: 3 months ]
    • Difference demonstrated between two groups on the ASES Shoulder Assessment from baseline to 3 months [ Time Frame: 3 months ]
    • Difference demonstrated between two groups on the Western Ontario Rotator Cuff Index from baseline to 3 months [ Time Frame: 3 months ]


    Original Primary Outcome:

    Current Secondary Outcome:

    • Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 weeks. [ Time Frame: 6 weeks ]
    • Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 months [ Time Frame: 6 months ]
    • Difference demonstrated between 2 groups on EQ-5D from baseline to 6 weeks [ Time Frame: 6 weeks ]
    • Difference demonstrated between the two groups on the Constant Shoulder Assessment from baseline to 6 months [ Time Frame: 6 months ]
    • Difference demonstrated between the two groups on the Oxford Shoulder Score from baseline to 6 months [ Time Frame: 6 months ]
    • Difference demonstrated between the two groups on the Western Ontario Rotator Cuff from baseline to 6 months [ Time Frame: 6 months ]
    • Difference demonstrated between 2 groups on EQ-5D from baseline to 3 months [ Time Frame: 3 months ]
    • Difference demonstrated between 2 groups on EQ-5D from baseline to 6 months [ Time Frame: 6 months ]
    • Difference demonstrated between 2 groups on EQ-5D from baseline to 12 months [ Time Frame: 12 months ]


    Original Secondary Outcome:

    Information By: DePuy International

    Dates:
    Date Received: September 13, 2005
    Date Started: July 2005
    Date Completion:
    Last Updated: July 1, 2016
    Last Verified: June 2016