Last updated: October 18, 2023
Sponsor: Medacta International SA
Overall Status: Active - Recruiting
Phase
N/A
Condition
Knee Replacement
Orthopedic Surgery
Arthritis And Arthritic Pain
Treatment
GMK SpheriKA
Clinical Study ID
NCT05459948
P.02.025.02
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients willing to sign the informed consent.
- Patients able to comply with follow-up requirements, including postoperativeweight-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.
Exclusion
Exclusion Criteria:
- 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 affectedjoint.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Patients with neuromuscular or neurosensory deficiency, which would limit the abilityto assess the performance of the device.
- Patients with a systemic or metabolic disorder leading to progressive bonedeterioration.
- Patients that are immunologically compromised or receiving chronic steroids (> 30days).
- Patients whose bone stock is compromised due to disease or infection, unable toprovide adequate support and/or fixation to the prosthesis.
- Patients with an active or suspected latent infection in or surrounding the kneejoint.
- Pregnant or breastfeeding women.
Study Design
Total Participants: 281
Treatment Group(s): 1
Primary Treatment: GMK SpheriKA
Phase:
Study Start date:
July 30, 2022
Estimated Completion Date:
May 31, 2035
Study Description
Connect with a study center
Centre de l'Arthrose
Mérignac,
FranceActive - Recruiting
Clinique de l'Union
Saint-Jean, 31240
FranceActive - Recruiting
Humanitas Castelli
Bergamo,
ItalyActive - Recruiting
Gelenkzentrum Winterthur
Winterthur,
SwitzerlandActive - Recruiting
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