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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT01469806
Brief Summary:
The primary objective of the Registry is to allow for tracking of FDA approved and/or cleared knees used in primary, revision, unicompartmental or partial total knee arthroplasty (TKA). Second, it is our desire to assist orthopaedic surgeons in obtaining and evaluating radiographic and functional outcomes data on their PFJ patients using current published guidelines. Third, within this Registry, subsets of data on newer technology are being collected for the purpose of future publications. The Patello-Femoral Joint Post Market Clinical (PFJ PMCF) study is one such subset.
Detailed Description:
To obtain preoperative, operative and postoperative clinical outcomes data for the Zimmer Gender Solutions PFJ Knee Prosthesis used in primary partial knee arthroplasty such as knee scoring and patient satisfaction such collection using Patient Questionaire and SF-12 forms. Kaplan-Meir survivorship analysis of the device will be performed. Radiographic analysis of the device will also be performed at 1, 2, 3, 5, 7, and 10 year follow-up. It is planned that the resultant data will be pooled and published by the evaluating surgeons.
Study:
NCT01469806
Study Brief:
Protocol Section:
NCT01469806