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

NCT05253976 | Withdrawn

• 1 other identifier: MDRG2017-89MS-157K
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  From post-operative to final follow-up visit, 3-10 years

• EuroQol five-dimensional Health Questionnaire (EQ-5D-5L).

  From post-operative to final follow-up visit, 3-10 years

Study Arms (1)

Patients who received the NexGen TM Augmentation Patella

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

Insel Spital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 24, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034
• Last Updated: December 24, 2024

Record last verified: 2022-10

Locations

CH (1)