The Medacta GMK SpheriKA Post-Marketing Surveillance Study

NCT05459948 | Recruiting

• 1 other identifier: P.02.025.02
• Study Type: observational
• Target: 281
• Locations: 3 countries
• Sites: 4

Brief Summary

This is a Post-Marketing Surveillance of GMK SpheriKA knee stem prosthesis.

Conditions

Arthropathy; Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Primary objective will be evaluated with the Forgotten Joint score (FJS).

  study the efficacy of the treatment to make the patient forget the presence of the artificial joint in everyday life. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities

  6 weeks, from 1 to 10 years annually

Secondary Outcomes (6)

• patient-reported outcomes 1

  6 weeks, from 1 to 10 years annually

• Satisfaction and Expectations questionaires

  6 weeks, from 1 to 10 years annually

• Radiological outcomes

  pre-op, 6weeks, 1, 2,5,10 years

• Adverse events

  during surgical operation, 6weeks, 1,2,5,10 years

• Limb alignment

  on preoperative and 6-week x-rays

Interventions

GMK SpheriKA DEVICE

The first objective is to study the FJS of patients who were implanted a "GMK® SpheriKA" knee prosthesis using the kinematic alignment technique

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

281 participants are planned for the entire project (all sites combined). Patients requiring "GMK® SpheriKA" implanted via the kinematic alignment technique will be informed and enrolled during the preoperative visit. The study is conducted as standard of care treatment and participants will receive the same treatment and undergo the same postoperative assessments as non-participants.

You may qualify if:

• Patients willing to sign the informed consent.
• Patients able to comply with follow-up requirements, including postoperative weight-bearing restrictions and self-evaluations.
• Patients 18 - 80 years of age at the time of surgery.
• Patients requiring a primary total knee replacement (on label use).
• Patients with intact collateral ligaments.

You may not qualify if:

• Patients with inflammatory arthritis.
• Morbidly obese patients, with a body mass index (BMI) \> 40.
• Patients with a history of total or unicompartmental reconstruction of the affected joint.
• Patients that have had a high tibial osteotomy or femoral osteotomy.
• Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
• Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
• Patients that are immunologically compromised or receiving chronic steroids (\> 30 days).
• Patients whose bone stock is compromised due to disease or infection, unable to provide adequate support and/or fixation to the prosthesis.
• Patients with an active or suspected latent infection in or surrounding the knee joint.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Medacta International SA: lead

Study Sites (4)

Centre de l'Arthrose

Mérignac, France

RECRUITING

Clinique de l'Union

Saint-Jean, 31240, France

RECRUITING

Humanitas Castelli

Bergamo, Italy

RECRUITING

Gelenkzentrum Winterthur

Winterthur, Switzerland

RECRUITING

MeSH Terms

Conditions

Joint Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Central Study Contacts

Arianna Girardi

CONTACT

+41 91 696 60 60; girardi@medacta.ch

Study Design

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

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 15, 2022
• Study Start: July 30, 2022
• Primary Completion (Estimated): May 1, 2035
• Study Completion (Estimated): May 1, 2035
• Last Updated: September 29, 2025

Record last verified: 2025-03

Locations

FR (2); CH (1); IT (1)