Patello-Femoral Joint Post Market Clinical Follow-up Within the Knee Registry (PFJPMCF)
This study has been withdrawn prior to enrollment.
(Suspended pending internal review/direction of the company's focus. No sites ever engaged or collected data.)
First Posted: November 10, 2011
Last Update Posted: September 27, 2016
Information provided by (Responsible Party):
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Zimmer(R) Gender Solutions(TM) Patello-Femoral Joint Prothesis Used Within the Knee Registry Protocol|
Further study details as provided by Zimmer Biomet:
Primary Outcome Measures:
- Long-term Device survivorship for publication [ Time Frame: 10 Years ]
Secondary Outcome Measures:
- Radiographic analysis of enrolled subjects [ Time Frame: 10 years ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||October 2023|
|Estimated Primary Completion Date:||October 2023 (Final data collection date for primary outcome measure)|
1 - PFJ
Patients who require primary partial knee arthroplasty of the patello-femoral joint.
Device: Zimmer Gender Solutions PFJ Knee Prosthesis
Partial knee arthroplasty of the patello-femoral joint
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.
Contacts and Locations
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