Patello-Femoral Joint Post Market Clinical Follow-up Within the Knee Registry (PFJ PMCF)

This study has suspended participant recruitment.
(Suspended pending internal review/direction of the company's focus.)
Sponsor:
Information provided by (Responsible Party):
Zimmer, Inc.
ClinicalTrials.gov Identifier:
NCT01469806
First received: October 24, 2011
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Primary Partial Knee Arthroplasty
Patellofemoral Joint
Device: Zimmer Gender Solutions PFJ Knee Prosthesis

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Zimmer, Inc.:

Primary Outcome Measures:
  • Long-term Device survivorship for publication [ Time Frame: 10 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic analysis of enrolled subjects [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
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)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469806

Locations
United States, Idaho
ADA Orthopaedics
Boise, Idaho, United States, 83704
Sponsors and Collaborators
Zimmer, Inc.
  More Information

No publications provided

Responsible Party: Zimmer, Inc.
ClinicalTrials.gov Identifier: NCT01469806     History of Changes
Other Study ID Numbers: 04-400, 90-112
Study First Received: October 24, 2011
Last Updated: March 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Zimmer, Inc.:
Primary partial knee arthroplasty
patello-femoral joint

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014