PMCF Study on the Safety, Performance and Clinical Benefits Data of the NexGen TM Augmentation Patella

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2034-12-31

Brief Summary

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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

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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

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Rheumatoid Arthritis Non-inflammatory Degenerative Joint Disease Functional Deformity Revision Total Knee Arthroplasty

Keywords

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Post-Market Clinical Follow-Up Study Medical Device Performance Safety Clinical Benefits

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Patients who received the NexGen TM Augmentation Patella

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hassan Achakri

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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Insel Spital

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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MDRG2017-89MS-157K

Identifier Type: -

Identifier Source: org_study_id