Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2025-12-24 @ 5:12 PM
NCT ID:
NCT05788250
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).
Study:
NCT05788250
Study Brief:
Protocol Section:
NCT05788250