Clinical and radiological evaluation of Signature™ Unicompartmental knee arthroplasty A Prospective, Multi-centre, Randomized, Double blind study Orbis Medisch Centrum, Sittard, the Netherlands.

Clinical evaluation of the Signature™ UKA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25746

Enrollment

120

Registered

2013-11-26

Start date

2014-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients who require UKA as a result of medial osteoarthritis of the knee and are candidates for the Oxford UKA system. medial osteoarthritis, PKA, UKA Oxford knee system

Interventions

Signature™ for UKA utilizes patient specific femoral and tibial positioning guides, developed from MRI. The guides are made of polyamide and are disposable. The Signature™ system, which fits the femor

Eligibility

Inclusion criteria

Inclusion criteria: -Patients scheduled to undergo primary UKA replacement with any of the following indications • Painful and disabled knee joint resulting from osteoarthritis of the medial knee compartment. • High need to obtain pain relief and improve function, -Above 18 years old (full skeletal maturity). -Body-mass-index (BMI) <35 -Ablility and willingness to follow nstructions, including control of weight and iactivity level, and to return for follow-up evaluations. -Consent form read, understood and signed by patient.

Exclusion criteria

Exclusion criteria: -Patients with osteoarthritis of more than only the medial knee compartment -Active infection in knee -General infection -Distant foci of infections which may spread to the implant site -Failure of previous joint replacement -Pregnancy -Previous major knee surgery, except for arthroscopic meniscectomy. -Metal near knee joint (MRI-scan not possible) -Not able or willing to undergo MRI-scan -Reumatoid arthritis -Extension deficit of more than 15 degrees -Flexion less than 110 degrees -Non-correctable varus axis -Cruciate ligament insufficiency

Design outcomes

Primary

Measure	Time frame
Primary outcome is relief of pain and restoration of function, measured by the Oxford knee score (OKS), at 1 year post-operative. Furthermore, this questionnaire will be completed in all post-operative visits. In order to measure positioning of the prosthesis long-leg, weight-bearing, standing anteroposterior and screened antero-posterior and lateral radiographs will be made at 6 weeks post-operative. The baseline mechanical axis will be measured as the angel between a line connecting the center of the femoral head with the center of the knee and the line connecting the center of the knee with the center of the ankle. Measurements will be performed by an orthopaedic resident.	—

Measure

Time frame

Primary outcome is relief of pain and restoration of function, measured by the Oxford knee score (OKS), at 1 year post-operative. Furthermore, this questionnaire will be completed in all post-operative visits. In order to measure positioning of the prosthesis long-leg, weight-bearing, standing anteroposterior and screened antero-posterior and lateral radiographs will be made at 6 weeks post-operative. The baseline mechanical axis will be measured as the angel between a line connecting the center of the femoral head with the center of the knee and the line connecting the center of the knee with the center of the ankle. Measurements will be performed by an orthopaedic resident.

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Secondary

Measure	Time frame
Relief of pain, restoration of function and patient satisfaction as determined by answers to patient outcomes questionnaires: American Knee Society Score, WOMAC, Oxford Knee-12, VAS and EQ-5D. •American Knee Society Score, WOMAC and Oxford Knee-12, VAS, EQ-5D at pre operative, 3 months, 1 year, 2 years, 5 and10 years postoperative. KSS and VAS will be obtained by a physician assistant or nurs practioner who was not present when operation was being performed and is therefore blinded concerning the type of prosthesis that is being placed. WOMAC, Oxford Knee-12 and EQ-5D will be completed by the patients. Operation time Time will be recorded from the moment of incision until bandage is being placed. In order to also measure the possible gain in time for the operative procedure as a whole, time will be recorded from the moment personnel starts to install materials on sterile fields until bandage is being placed. Recorded times will be registered by the knee surgeon on the standard operative record for each patient individually and in the study database for all patients participating in the trial. Length of hospital stay (in days) will be registered for both groups. Adverse events/complications Complication registration will be done throughout the entire study period on a digital complication registration form •Infection Infection lab values (ESR, CRP, leukocytes) will be measured on day 3 post-operative to screen for the presence of infection. When infection is indeed present, this will be noted on the complication registry form and appropriate action will be taken. Distinction will be made clinically between superficial infections and deep infections. •Trombo-embolic complications Attention will be focused on clinical signs of deep vein thrombosis and pulmonary embolism. When clinical signs are present, diagnostic tools will be used to analyse if DVT or PE are indeed present. If DVT or PE are indeed present, this will be noted on the complication registrat	—

Measure

Time frame

Relief of pain, restoration of function and patient satisfaction as determined by answers to patient outcomes questionnaires: American Knee Society Score, WOMAC, Oxford Knee-12, VAS and EQ-5D. •American Knee Society Score, WOMAC and Oxford Knee-12, VAS, EQ-5D at pre operative, 3 months, 1 year, 2 years, 5 and10 years postoperative. KSS and VAS will be obtained by a physician assistant or nurs practioner who was not present when operation was being performed and is therefore blinded concerning the type of prosthesis that is being placed. WOMAC, Oxford Knee-12 and EQ-5D will be completed by the patients. Operation time Time will be recorded from the moment of incision until bandage is being placed. In order to also measure the possible gain in time for the operative procedure as a whole, time will be recorded from the moment personnel starts to install materials on sterile fields until bandage is being placed. Recorded times will be registered by the knee surgeon on the standard operative record for each patient individually and in the study database for all patients participating in the trial. Length of hospital stay (in days) will be registered for both groups. Adverse events/complications Complication registration will be done throughout the entire study period on a digital complication registration form •Infection Infection lab values (ESR, CRP, leukocytes) will be measured on day 3 post-operative to screen for the presence of infection. When infection is indeed present, this will be noted on the complication registry form and appropriate action will be taken. Distinction will be made clinically between superficial infections and deep infections. •Trombo-embolic complications Attention will be focused on clinical signs of deep vein thrombosis and pulmonary embolism. When clinical signs are present, diagnostic tools will be used to analyse if DVT or PE are indeed present. If DVT or PE are indeed present, this will be noted on the complication registrat

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Contacts

Public ContactM.G.M. Schotanus

Department of Orthopedic Surgery, Orbis Medisch Centrum dr H vd Hoffplein 1

m.schotanus@zuyderland.nl+31 (0)88 4597823

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)