Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
Study NCT ID:
NCT05788250
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RC Repair Versus Subacromial Balloon Spacer in Older Adults
Sponsor:
Panam Clinic
Organization:
Study Overview
Official Title:
Randomized Clinical Trial Comparing Rotator Cuff Repair (RCR) With Subacromial Balloon Spacer (SBS) Implantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
The purpose of this pilot study is to assess the feasibility of a full randomized trial design.
Detailed Description:
The feasibility objectives are:
1. Recruitment
1. To establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent.
2. To establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears.
2. Surgery -to confirm agreement among surgeons regarding the protocol's standardized surgical techniques of both groups.
Clinical objectives for observational purposes only are as follows:
1. Patient reported and clinical outcomes.
2. Number of "failures" in each group (defined as additional surgery and/or having \<12% improvement in SANE score from baseline).
1. Recruitment
1. To establish an estimate of the proportion of patients screened who are eligible for inclusion, and of those, the proportion who consent.
2. To establish an estimate of the proportion of eligible patients with medium/large tears versus massive tears.
2. Surgery -to confirm agreement among surgeons regarding the protocol's standardized surgical techniques of both groups.
Clinical objectives for observational purposes only are as follows:
1. Patient reported and clinical outcomes.
2. Number of "failures" in each group (defined as additional surgery and/or having \<12% improvement in SANE score from baseline).
Study Oversight
Has Oversight DMC:
False
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?: