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MAKO-Uni-Knee Arthroplasty Clinical Outcomes and Function

NCT03354195 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-02-05

No results posted yet for this study

Summary

This study represents a single-surgeon/institution, non-randomized, consecutive series, prospective and comparative cohort design. The Principal Investigator is anticipating 100 study patients in the INTACT group and 35 patients in the Anterior Cruciate Ligament-Deficient group.The schedule of events lists the imaging procedures and questionnaires to be completed at each visit.

Subjects will be consented and enrolled within 28 days prior to surgery and participate in follow-up visits for two years following their Unicompartmental Knee Arthroplasty. A 3-year enrollment duration is anticipated to enroll a minimum and consecutive series of 25 patients in the experimental Anterior Cruciate Ligament-deficient group. Over the same enrollment duration, 100+ patients with intact Anterior Cruciate Ligaments are expected to be in the control group and undergo Unicompartmental Knee Arthroplasty. The enrollment duration (3 years) and total study duration (5 years) are based on patient volume estimates provided by the Principal Investigator.

Conditions

  • Clinical Outcomes

Interventions

PROCEDURE

Unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.

All patients will receive the RESTORIS MCK (Multicompartmental Knee) Implant System, which is approved for use in unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system. The femoral component is constructed from cobalt chrome (CoCr) and the tibial component is constructed from an ultra-high molecular weight polyethylene (UHMWPE) insert and titanium (Ti) baseplate. UKA will be facilitated with MAKO Robotic-Arm Assisted Surgery, which has been shown in prior studies to lower pain and result in more accurate implant placement than manual UKA in a randomized controlled trial.(15)

Sponsors & Collaborators

  • Stryker Orthopaedics

    collaborator INDUSTRY

  • Foundation for Orthopaedic Research and Education

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2020-01-30
Completion
2020-01-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03354195 on ClinicalTrials.gov