Rheumatoid ArthritisNCT05253976
PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella
An observational study of Rheumatoid Arthritis and Non-inflammatory Degenerative Joint Disease, run by Zimmer Biomet at 1 site in Switzerland.
Trial summary
The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the NexGen TM Augmentation Patella. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease, Functional Deformity
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2022to 31 Dec 2034
- 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: The study population will be comprised of a consecutive series of patients who have been operated with the NexGen TM Augmentation Patella according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Non-inflammatory degenerative joint disease including osteoarthritis or traumatic arthritis
- Rheumatoid arthritis
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed
- Treatment of fractures that are unmanageable using other techniques
- Complication from a failed prosthesis
- For cementless use only
- Supplemental fixation, when required, must be achieved by means of suture attachment.
Who cannot join
- Off-label use
- Primary arthroplasty
- Overt Infection
- Distant foci of infection (which may spread hematogenously to the implant site)
- Rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram
- Skeletally immature patients
Show all 9Show fewer
- Cases where there is inadequate bone stock or no bone stock which would make the procedure unjustifiable
- Patients who are not willing to return for study required follow-up visits and/or are not willing to comply with the follow-up schedule
- Patient who is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant, younger than 18 years)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-market Clinical Follow-up Study to Confirm Safety, Performance and Clinical Benefits Data of the NexGen® Trabecular Metal™ (TM) Augmentation Patella (Implants and Instrumentation)- A Retrospective and Prospective Consecutive Series Study
The study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the NexGen TM Augmentation Patella. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.
Read the detailed description
The Nexgen TM Augmentation Patella is intended to help compensate for significant bone loss in the patella during revision total knee arthroplasty.
One site will be involved in this study. The aim is to include a total of 25 consecutive series patients who received the NexGen TM Augmentation Patella starting from 2014 at the Inselspital Bern. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1, 3, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
- Conditions
- Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease, Functional Deformity, Revision Total Knee Arthroplasty
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received the NexGen TM Augmentation Patella | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and frequency of revisions, complications and adverse events.
Safety will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events.
Measured: From operation to study completion, 3-10 years
Secondary outcomes (2)
Knee injury and Osteoarthritis Outcome Score (KOOS)
The KOOS assesses the patient's opinion about their knee and associated problems and consists of 5 subscales. Standardized answer options are given and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Measured: From post-operative to final follow-up visit, 3-10 years
EuroQol five-dimensional Health Questionnaire (EQ-5D-5L).
The EQ-5D-5L is a generic instrument . The EQ is scored on a 0 to 100 mm scale representing "the worst..." and "the best health you can imagine", respectively.
Measured: From post-operative to final follow-up visit, 3-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study startSep 2022 (estimated)
- Primary completion31 Dec 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Why it stopped: Study had to be terminated before first patient got enrolled due to insufficient case number.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid 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
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Achakri, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253976
- Sponsor's protocol ID
- MDRG2017-89MS-157K
- Status last verified
- Oct 2022
- First submitted
- 12 Jan 2022
- Last updated
- 24 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study to Confirm Safety, Performance and Clinical Benefits Data of the NexGen® Trabecular Metal™ (TM) Augmentation Patella (Implants and Instrumentation)- A Retrospective and Prospective Consecutive Series Study
- ClinicalTrials.gov ID
- NCT05253976
- Acronym / sponsor ID
- MDRG2017-89MS-157K
- Conditions
- Rheumatoid Arthritis, Non-inflammatory Degenerative Joint Disease, Functional Deformity, Revision Total Knee Arthroplasty
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study had to be terminated before first patient got enrolled due to insufficient case number.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- 31 Dec 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 24 Feb 2022 (actual)
- 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 study is a single-center, retrospective and prospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the NexGen TM Augmentation Patella. The primary objective is the assessment of safety by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.
The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcome measures (PROMs) as well as radiographic outcomes.
Detailed description
The Nexgen TM Augmentation Patella is intended to help compensate for significant bone loss in the patella during revision total knee arthroplasty.
One site will be involved in this study. The aim is to include a total of 25 consecutive series patients who received the NexGen TM Augmentation Patella starting from 2014 at the Inselspital Bern. All potential study subjects will be required to participate in the Informed Consent Process.
Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1, 3, 5, 7 and 10 years post-op (depending on patients' date of surgery), the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment and a radiographic evaluation will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received the NexGen TM Augmentation Patella | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be comprised of a consecutive series of patients who have been operated with the NexGen TM Augmentation Patella according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (8 listed)
- Non-inflammatory degenerative joint disease including osteoarthritis or traumatic arthritis
- Rheumatoid arthritis
- Correction of functional deformity
- Revision procedures where other treatments or devices have failed
- Treatment of fractures that are unmanageable using other techniques
Key exclusion criteria (9 listed)
- Off-label use
- Primary arthroplasty
- Overt Infection
- Distant foci of infection (which may spread hematogenously to the implant site)
- Rapid disease progression as manifested by joint destruction or bone resorption apparent on roentgenogram
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence and frequency of revisions, complications and adverse events.
Time frame: From operation to study completion, 3-10 years
Safety will be assessed by recording and analyzing the incidence and frequency of revisions, complications and adverse events.
2 secondary outcomes
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: From post-operative to final follow-up visit, 3-10 years
EuroQol five-dimensional Health Questionnaire (EQ-5D-5L).
Time frame: From post-operative to final follow-up visit, 3-10 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 24 Dec 2024.
Related trials for Rheumatoid Arthritis
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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.
Hassan Achakri study director
Zimmer Biomet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Non-inflammatory Degenerative Joint Disease, run by Zimmer Biomet at 1 site in Switzerland.
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 8 inclusion and 9 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 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The incidence and frequency of revisions, complications and adverse events. (time frame: From operation to study completion, 3-10 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 24 Dec 2024.