NCT01469806

Patello-Femoral Joint Post Market Clinical Follow-up Within the Knee Registry

Zimmer(R) Gender Solutions(TM) Patello-Femoral Joint Prothesis Used Within the Knee Registry Protocol

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis

Interventions

Type	Name	Description
DEVICE	Zimmer Gender Solutions PFJ Knee Prosthesis	Partial knee arthroplasty of the patello-femoral joint

Timeline

• Start date: 2011-11-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2011-11-10
• Last updated: 2016-09-27