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:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT03021733
Brief Summary:
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.
Detailed Description:
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.
Study:
NCT03021733
Study Brief:
Protocol Section:
NCT03021733