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

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.

Study Overview

• Status: Withdrawn
• Conditions: Rheumatoid Arthritis; Revision Total Knee Arthroplasty; Non-inflammatory Degenerative Joint Disease; Functional Deformity

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 Type: Observational

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Insel Spital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients who received the NexGen TM Augmentation Patella

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From operation to study completion, 3-10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From post-operative to final follow-up visit, 3-10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2022
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): February 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Performance; Medical Device; Clinical Benefits; Post-Market Clinical Follow-Up Study
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Joint Diseases; Osteoarthritis
• Other Study ID Numbers: MDRG2017-89MS-157K

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No