Patello-Femoral Joint Post Market Clinical Follow-up Within the Knee Registry (PFJPMCF)
Zimmer(R) Gender Solutions(TM) Patello-Femoral Joint Prothesis Used Within the Knee Registry Protocol
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient is greater than 18 years of age;
- Patient selection is without bias to race or gender;
- Patient is in stable health and able to undergo surgery;
Patient has patellofemoral joint(s) affected by disease process and/or injury and qualifying for primary unilateral or bilateral replacement of the femoral trochlea based a primary diagnosis of at least one of the following:
- Osteoarthritis
- Traumatic Arthritis
- Polyarthritis
- Severe Chondrocalcinosis
- Salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation)
- History of patellar dislocation or patella fracture
- Dysplasia-induced patellofemoral degeneration
- Patient is willing and able to cooperate in prescribed post-operative therapy;
- Patient is willing and able to complete scheduled follow-up evaluations as described in the Informed Consent;
- Patient has participated in the Informed Consent process and has signed an IRB approved Informed Consent.
- Patient has not history of previous prosthetic replacement device(s) of any type in the affected knee joint;
- Independent of study participation, patient is scheduled to receive treatment using a Zimmer Gender Solutions Patellofemoral Joint Prosthesis (PFJ).
Exclusion Criteria:
- Patient with an acute, chronic, local or systemic infection;
- Patient is skeletally immature;
- Patient is pregnant;
- Patient is a prisoner, mentally incompetent or anticipated to be non-compliant. Patient has a known allergy to one of the constituents of the implant, e.g. cobalt, chromium, nickel, etc.;
- Patient has Rheumatoid Arthritis (RA) AND an ulcer of the skin OR a history of recurrent breakdown of the skin;
- Patient has neuropathic arthropathy, neuromuscular disorder, neurologic condition, vascular disorder, systemic disease and/or other condition that affects lower limb function and/or could contribute to prosthesis instability, prosthesis fixation failure, and/or complications in postoperative care;
- Patient has a Body Mass Index (BMI) greater than 40;
- Patient has insufficient native bone stock in the operative joint (e.g. osteoporosis, osteonecrosis, tumors, cysts, etc.). Note: Bone void fillers are NOT considered native bone stock, even if autograft is used;
- Patient has severe instability, maltracking, or malalignment of the patella, patellofemoral, and/or tibiofemoral joints;
- Patient has patellectomy of the affected joint, including previous patellectomy, patellectomy performed simultaneous to study PFA, or scheduled patellectomy;
- Patient has insufficient menisci and/or ligament structures (e.g. non-functional/absent ACL and/or PCL);
Patient exhibits tibiofemoral degeneration and/or Outerbridge grade greater than or equal to 3 in EITHER:
- one (medial or lateral) tibiofemoral compartment that is not treated with a simultaneous compatible Zimmer unicompartmental knee replacement; OR
- both (medial AND lateral) tibiofemoral compartments, regardless of treatment.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
1 - PFJ
Patients who require primary partial knee arthroplasty of the patello-femoral joint.
|
Partial knee arthroplasty of the patello-femoral joint
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Long-term Device survivorship for publication
Time Frame: 10 Years
|
10 Years
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Radiographic analysis of enrolled subjects
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Anticipated)
Primary Completion
Study Completion (Anticipated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 04-400
- 90-112 (Other Identifier: Zimmer, Inc)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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