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

NCT01469806 | Withdrawn

• 2 other identifiers: 04-40090-112
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• Long-term Device survivorship for publication

  10 Years

Secondary Outcomes (1)

• Radiographic analysis of enrolled subjects

  10 years

Study Arms (1)

1 - PFJ

Patients who require primary partial knee arthroplasty of the patello-femoral joint.

Device: Zimmer Gender Solutions PFJ Knee Prosthesis

Interventions

Zimmer Gender Solutions PFJ Knee Prosthesis DEVICE

Partial knee arthroplasty of the patello-femoral joint

1 - PFJ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2011
• First Posted: November 10, 2011
• Study Start: November 1, 2011
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 27, 2016

Record last verified: 2012-03

Data Sharing

• IPD Sharing: Will not share