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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05253976
• Other study ID #: MDRG2017-89MS-157K
• Status: Withdrawn
• Start date: September 1, 2022
• Est. completion date: December 31, 2034

Study information

• Verified date: October 2022
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2034
• Est. primary completion date: December 31, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Joint Diseases
• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis
• Revision Total Knee Arthroplasty
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Switzerland	Insel Spital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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