A Trial Evaluating TKR Compared to BKR Performed Using Stryker's Mako Robot
NCT ID: NCT02650284
Last Updated: 2022-06-29
Study Results
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View full resultsBasic Information
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TERMINATED
NA
18 participants
INTERVENTIONAL
2015-08-12
2019-03-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Bicompartmental Knee Replacement (BKR)
Receiving Restoris MCK Multicompartmental Knee System for Bicompartmental Knee Replacement (BKR). Surgery performed using Stryker's robotic-arm assisted surgery system Mako
Restoris MCK Multicompartmental Knee System
Bicompartmental Knee Replacement
Total Knee Replacement (TKR)
Receiving Stryker Triathlon Primary Total Knee System for Total Knee Replacement. Surgery performed using Stryker's robotic-arm assisted surgery system Mako
Stryker Triathlon Primary Total Knee System
Total Knee Replacement
Interventions
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Stryker Triathlon Primary Total Knee System
Total Knee Replacement
Restoris MCK Multicompartmental Knee System
Bicompartmental Knee Replacement
Eligibility Criteria
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Inclusion Criteria
2. The patient has no fixed flexion greater than 10 degrees.
3. The patient has maximal flexion greater than 100 degrees
4. The patient has a passively correctable varus deformity
5. The patient has a functionally Intact Anterior Cruciate Ligament (ACL.)
6. The patient has no significant patellofemoral malalignment
7. The patient has negligible lateral compartment degeneration with no appreciable loss of cartilage height (surgeon's discretion).
8. The patient has pain that is not localised to the medial compartment only
9. The patient is a male or non-pregnant female.
10. The patient has signed the study specific, Human Research Ethics Committee (HREC)- approved Informed Consent document and is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations
Exclusion Criteria
2. The patient is undergoing revision surgery
3. The patient has greater than 10° of hyperextension, greater than 10° of varus or valgus deformity, greater than 10° Flexion Contracture
4. The patient has active, local infection or previous intra-articular infection
5. The patient has skeletal immaturity
6. The patient is without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis
7. The patient's weight, age or activity level might cause extreme loads and early failure of the system (surgeons discretion).
8. The patient has a systemic or local condition that would limit the ability to assess the performance of the device e.g. neuromuscular or neurosensory deficiency, disorder leading to progressive bone deterioration (including rheumatoid arthritis and osteoporosis), or patient is immunologically suppressed.
9. Patient has a cognitive impairment, an intellectual disability or a mental illness that is considered by the investigator to inhibit the patient's capacity to consent to research and the ability to participate in it
10. Patients with tricompartmental disease are contraindicated from the study
18 Years
ALL
No
Sponsors
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Stryker South Pacific
INDUSTRY
Responsible Party
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Principal Investigators
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Gavin Clark, Dr
Role: PRINCIPAL_INVESTIGATOR
Perth Hip and Knee and St John of God Hospital
Locations
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Perth Hip & Knee
Subiaco, Western Australia, Australia
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Patients receiving CT but NO Arthrogram
Document Type: Informed Consent Form: Patients receiving CT WITH Arthrogram
Other Identifiers
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MAKORCT-15
Identifier Type: -
Identifier Source: org_study_id
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