Last updated: December 12, 2023
Sponsor: Reinier Haga Orthopedisch Centrum
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
Condylar Stabilizing (CS) insert
Cruciate Retaining (CR) insert
Clinical Study ID
NCT05936593
OC-2021-004
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients scheduled to undergo primary total knee replacement with the MAKO-roboticarm, with one of the following indications:
- Painful, disabling joint disease of the knee resulting from: non-inflammatorydegenerative joint disease (including osteoarthritis, traumatic arthritis or avascularnecrosis) or rheumatoid arthritis.
- One or more compartments are involved;
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures canbe returned to adequate function and stability (meaning a varus, valgus or flexiondeformity < 15 degrees);
- Age between 18 and 70 years;
- ASA score I or II;
- A good nutritional state of the patient;
- Patients with a completely intact PCL at the time of surgery;
- Patient is able to understand the study and is willing to participate and to sign theInformed Consent;
- Patient is able to speak and write Dutch.
Exclusion
Exclusion Criteria:
- Contraindications manufacturer:
- Any active or suspected latent infection in or about the knee joint;
- Distant foci of infection which may cause hematogenous spread to the implant site;
- Any mental or neuromuscular disorder which would create an unacceptable risk ofprosthesis instability, prosthesis fixation failure, or complications in postoperativecare;
- Bone stock compromised by disease, infection or prior implantation which cannotprovide adequate support and/or fixation to the prosthesis;
- Skeletal immaturity;
- Severe instability of the knee joint secondary to the absence of collateral ligamentintegrity and function;
- Metal in the operative or non-operative leg which lead to the creation ofaccuracy-reducing artefacts in the CT scan;
- Body Mass Index (BMI) of > 35 kg/m2;
- Flexion contracture of 15 degrees and more;
- Varus/valgus contracture of 15 degrees and more;
- History of total or unicompartmental reconstruction of the affected joint;
- Bilateral operation;
- A Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within thelast year that is considered to have an unsatisfactory outcome (Patients withcontralateral and/or ipsilateral THA > 1 year ago with good outcome can be included inthe study);
- A Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that isconsidered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6months ago with good outcome can be included in the study);
- Patients who will need lower limb joint replacement for another joint within one year.
- Active or suspected latent infection in or about the knee joint;
- Osteomyelitis;
- Sepsis;
- A systemic or metabolic disorder leading to progressive bone deterioration, excludingrheumatoid arthritis;
- Vascular insufficiency, muscular atrophy;
- Neuromuscular or neurosensory deficiency, which would limit the ability to assess theperformance of the device;
- Female patients planning a pregnancy during the course of the study;
- The patient is immunologically suppressed or receiving steroids in excess of normalphysiological requirements.
- Patients bone stock is compromised by disease or infection which cannot provideadequate support and/or fixation to the prosthesis;
- A knee fusion to the affected joint;
- Patient has a known or suspected sensitivity or allergy to one or more of the implantmaterials;
Study Design
Total Participants: 44
Treatment Group(s): 2
Primary Treatment: Condylar Stabilizing (CS) insert
Phase:
Study Start date:
July 21, 2023
Estimated Completion Date:
June 30, 2035
Connect with a study center
Reinier Haga Orthopedisch Centrum
Zoetermeer, Zuid-Holland 2725 NA
NetherlandsActive - Recruiting
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