ArthritisPFJPMCFNCT01469806
Patello-Femoral Joint Post Market Clinical Follow-up Within the Knee Registry
An observational study of Arthritis, run by Zimmer Biomet.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis
- What is being tested?
- Zimmer Gender Solutions PFJ Knee Prosthesis
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2011to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
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- 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).
Who cannot join
- 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;
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- 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.
About this study
Official title: Zimmer(R) Gender Solutions(TM) Patello-Femoral Joint Prothesis Used Within the Knee Registry Protocol
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.
Read the 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
- Being tested
- Zimmer Gender Solutions PFJ Knee Prosthesis
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zimmer Gender Solutions PFJ Knee ProsthesisDevice
Partial knee arthroplasty of the patello-femoral joint
| Study group | Role | What they receive |
|---|---|---|
| 1 - PFJ | Patients who require primary partial knee arthroplasty of the patello-femoral joint. Receives: Device: Zimmer Gender Solutions PFJ Knee Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Device survivorship for publication
Measured: 10 Years
Secondary outcomes (1)
Radiographic analysis of enrolled subjects
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Why it stopped: Suspended pending internal review/direction of the company's focus. No sites ever engaged or collected data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469806
- Sponsor's protocol ID
- 04-400
- Other IDs
- 90-112
- Acronym
- PFJPMCF
- Status last verified
- Mar 2012
- First submitted
- 24 Oct 2011
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zimmer(R) Gender Solutions(TM) Patello-Femoral Joint Prothesis Used Within the Knee Registry Protocol
- ClinicalTrials.gov ID
- NCT01469806
- Acronym / sponsor ID
- PFJPMCF / 04-400
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Suspended pending internal review/direction of the company's focus. No sites ever engaged or collected data.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 - PFJ | – | Device: Zimmer Gender Solutions PFJ Knee ProsthesisPatients who require primary partial knee arthroplasty of the patello-femoral joint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (16 listed)
- 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:
- Patient is willing and able to cooperate in prescribed post-operative therapy;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zimmer Gender Solutions PFJ Knee ProsthesisPartial knee arthroplasty of the patello-femoral joint | Device | 1 - PFJ |
Primary outcome
Long-term Device survivorship for publication
Time frame: 10 Years
1 secondary outcome
Radiographic analysis of enrolled subjects
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Zimmer Biomet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term Device survivorship for publication (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2016.