Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208338
Status:
COMPLETED
Last Update Posted:
2016-07-04
First Post:
2005-09-13
Brief Title:
Pilot Study to Evaluate the Restore Orthobiologic Implant in Rotator Cuff Tear Repair
Sponsor:
DePuy International
Organization:
DePuy International
Study Overview
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
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None