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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208338
• Other study ID #: CT 04/17
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: July 1, 2016
• Start date: July 2005
• Est. completion date: April 2015

Study information

• Verified date: June 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyBelgium: Institutional Review Board
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2015
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

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

Intervention

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

Locations

Country	Name	City	State
Belgium	U.Z. Gasthuis Berg	Leuven
United Kingdom	Royal Liverpool University Hospital	Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference demonstrated between two groups on the Oxford Shoulder Score from baseline to 3 months		3 months	No
Primary	Difference demonstrated between two groups on the Constant Shoulder Assessment from baseline to 3 months		3 months	No
Primary	Difference demonstrated between two groups on the ASES Shoulder Assessment from baseline to 3 months		3 months	No
Primary	Difference demonstrated between two groups on the Western Ontario Rotator Cuff Index from baseline to 3 months		3 months	No
Secondary	Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 weeks.		6 weeks	No
Secondary	Difference demonstrated between the two groups on the ASES Shoulder Assessment from baseline to 6 months		6 months	No
Secondary	Difference demonstrated between 2 groups on EQ-5D from baseline to 6 weeks		6 weeks	No
Secondary	Difference demonstrated between the two groups on the Constant Shoulder Assessment from baseline to 6 months		6 months	No
Secondary	Difference demonstrated between the two groups on the Oxford Shoulder Score from baseline to 6 months		6 months	No
Secondary	Difference demonstrated between the two groups on the Western Ontario Rotator Cuff from baseline to 6 months		6 months	No
Secondary	Difference demonstrated between 2 groups on EQ-5D from baseline to 3 months		3 months	No
Secondary	Difference demonstrated between 2 groups on EQ-5D from baseline to 6 months		6 months	No
Secondary	Difference demonstrated between 2 groups on EQ-5D from baseline to 12 months		12 months	No