Ignite Creation Date:
2024-05-06 @ 3:23 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04615117
Status:
RECRUITING
Last Update Posted:
2021-10-12
First Post:
2020-10-22
Brief Title:
An Outcomes Study Utilizing AllomendR HD for Superior Capsular Reconstruction
Sponsor:
Western Orthopaedics Research and Education Foundation
Organization:
Western Orthopaedics Research and Education Foundation
Study Overview
Official Title:
An Outcomes Study Utilizing AllomendR HD for Superior Capsular Reconstruction
Status:
RECRUITING
Status Verified Date:
2021-10
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:
Rotator cuff tears can usually be repaired with excellent results however some chronic extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity muscle atrophy and fatty infiltration Arthroscopic superior capsular reconstruction SCR utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tears Grafts utilized for SCR have included fascia lata hamstring autograft human acellular dermal tissue matrix HADTM and acellular porcine dermal xenograft Due to donor morbidity associated with autografts and the graft rejection potential of xenograft HADTM has become a common graft of choice for SCR The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes
Detailed Description:
Rotator cuff tears can usually be repaired with excellent results however some chronic extensive rotator cuff tears are not reparable secondary to tendon retraction with inelasticity muscle atrophy and fatty infiltration Arthroscopic superior capsular reconstruction SCR utilizing allograft or autograft tissue has been shown to restore superior glenohumeral stability and function of the shoulder joint in patients with irreparable rotator cuff tearsGrafts utilized for SCR have included fascia lata hamstring autograft human acellular dermal tissue matrix HADTM and acellular porcine dermal xenograft Due to donor morbidity associated with autografts and the graft rejection potential of xenograft HADTM has become a common graft of choice for SCR The purpose of this study is to determine if patients treated with SCR using AlloMend have acceptable clinical and anatomic outcomes We predict there will be significant improvement in radiographic clinical and patient reported outcomes in patients undergoing SCR for extensive primarily irreparable rotator cuff tears when AlloMend allograft is utilized
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None