Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182299
Status:
UNKNOWN
Last Update Posted:
2007-04-20
First Post:
2005-09-13
Brief Title:
An RCT to Compare the Outcomes of Patients With Large Rotator Cuff Repair That Undergo Repair With or Without SIS
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
A Randomized Clinical Trial Comparing the Effectiveness of Rotator Cuff Repair With or Without Augmentation With Porcine Small Intestine Submucosa SIS for Large Rotator Cuff Tears Pilot Study Phase
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The prognosis for patients with large rotator cuff tears is poor This recently developed biologic scaffold provides numerous structural and functional properties that may direct cell growth and aid in tendon healing To date there are no randomized clinical trials assessing the effectiveness of the patch to augment repairs of large rotator cuff tears We propose a study to compare the rate of repair failure quality of life function pain and range of motion in 60 patients with large rotator cuff Patients will be randomized like flipping a coin to undergo a standard rotator cuff repair with or without augmentation with SIS Patients are assessed at 6 weeks 3 6 12 18 and 24 months post-operative
Detailed Description:
Objective of the full randomized trial To compare the effectiveness of a standardized method of rotator cuff repair with or without augmentation using porcine small intestine submucosa SIS in patients with large rotator cuff tears
Objectives of the pilot study
1 To obtain a preliminary estimate of the likely success of SIS
2 To formally evaluate our ability to successfully recruit eligible patients into this study
3 To determine appropriate length of follow up through examination of the pattern of incremental improvement and stabilization of quality of life over time following rotator cuff repair
4 To determine a more accurate estimation of sample size for the full trial using quality of life
5 To determine the frequency with which surgeons comply with the surgical protocol
6 To determine the frequency with which patients and physiotherapists comply with the suggested physiotherapy protocol
Objectives of the pilot study
1 To obtain a preliminary estimate of the likely success of SIS
2 To formally evaluate our ability to successfully recruit eligible patients into this study
3 To determine appropriate length of follow up through examination of the pattern of incremental improvement and stabilization of quality of life over time following rotator cuff repair
4 To determine a more accurate estimation of sample size for the full trial using quality of life
5 To determine the frequency with which surgeons comply with the surgical protocol
6 To determine the frequency with which patients and physiotherapists comply with the suggested physiotherapy protocol
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