MAKO-Uni-Knee Arthroplasty Clinical Outcomes and Function

NCT03354195 | Completed

• 1 other identifier: MM-MAKO-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Functional and Clinical Outcomes comparing patients with and without intact Anterior Cruciate Ligaments undergoing arthroplasty with MAKO Robotic-Arm Assisted Surgery.

  Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline (screening), compared to a 24 month follow-up visit. There are also several additional time points from 3 weeks, 6 weeks, 3 months, 6 months and 12 months where the functional and clinical outcomes are assessed.

Secondary Outcomes (6)

• Height and Weight

  Baseline (screening)

• Computed Tomography

  Baseline (screening)

• Magnetic Resonance Imaging

  Baseline (screening)

• Radiographs (3 views)

  Baseline (screening)

• Global Satisfaction Survey

  Baseline (screening), 3 weeks, 6 weeks, 3 months, 12 months, 24 months

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Group 1 - intact ACL ligament will be accepted as functionally intact unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.

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

Group 2

ACTIVE COMPARATOR

Group 2 - intact but fibrillated (frayed) ligament) will be accepted as functionally intact unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.

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

Group 3

ACTIVE COMPARATOR

Group 3 - nearly completely torn ligament (\>50% and disrupted) will be deemed as having functionally absent ACLs unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.

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

Interventions

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

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)

Also known as: UKA with Mako Robotic Arm-assisted system

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet these criteria to participate in this study:
• Patients with isolated, symptomatic femorotibial knee arthritis and candidates for UKA;
• Patients ≥ 21 years old;
• Patients with intact and non-functional ACLs as determined through pre-operative imaging, knee laxity tests, rotational stability tests, and intraoperative ACL classification;
• Patients willing and able to sign an informed consent;
• Patients willing and able to comply with 2-year follow-up commitments.

You may not qualify if:

• Patients with RA;
• Patients with BMI \>40;
• Patients with ROM arc \> 75°;
• Patients with greater than 10º of hyperextension;
• Patients with greater than 15º of varus or valgus deformity;
• Patients with active infection;
• Patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis;
• Patients without sufficient soft tissue integrity to provide adequate stability;
• Patients with either mental or neuromuscular disorders that do not allow control of the knee joint;
• Patients whose weight, age or activity level might cause extreme loads and early failure of the system.

Sponsors & Collaborators

• Foundation for Orthopaedic Research and Education: lead
• Stryker Orthopaedics: collaborator

Study Sites (1)

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: During surgery, the ACL will be inspected, manually stressed and probed following standard techniques to assess its structure and function.(20, 21) The state of the ACL will be recorded and classified into one of four categories per these intra-operative examinations (22) and available pre-operative MRI data: Group 1 - intact ACL ligament Group 2 - intact but fibrillated (frayed) ligament) Group 3 - nearly completely torn ligament (\>50% and disrupted) Assessment will be performed by the PI. Knees with ACLs classified as Group 1 and Group 2 will be accepted as functionally intact. Those classified as Group 3 will be deemed as having functionally absent ACLs

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 27, 2017
• Study Start: July 1, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)