Survivorship and Outcomes of Robot Assisted Medial Partial Knee Replacement

NCT01845597 | Completed Results

• 2 other identifiers: MAKO-032016-006
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the survivorship rate of robotic assisted medial partial knee replacement at a two, five, and ten years.

Conditions

Unicompartmental Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 10 Year Survivorship of Components

  Survivorship of components is defined as knee implant device(s) remaining in patient.

  10 years after surgery

Secondary Outcomes (2)

• 5 Year Survivorship of Components

  5 years after surgery

• 2 Year Survivorship of Components

  2 years after surgery

Study Arms (1)

MAKOplasty® medial UKA

Patients knees that have received a MAKOplasty® robotically guided unicompartmental knee arthroplasty (UKA) and received a medial MCK onlay implant.

Procedure: MAKOplasty® medial UKA

Interventions

MAKOplasty® medial UKA PROCEDURE

A robot guided medial Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.

Also known as: Medial Partial Knee Replacement, Medial Unilateral Knee Arthroplasty, Robot Assisted Partial Knee Replacement

MAKOplasty® medial UKA

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a MAKOplasty procedure by the investigating surgeon and received a medial MCK onlay implant.

You may qualify if:

• over 21 years of age
• underwent primary robotically guided UKA and received a medial MCK onlay implant by the investigating surgeon
• at least 24 months post-operative

You may not qualify if:

• Patients will be excluded from participation in the study if they are cognitively unable to answer study questions

Sponsors & Collaborators

• Northwest Surgical Specialists, Vancouver: lead
• Stryker Instruments: collaborator

Study Sites (1)

Rebound Orthopedics and Neurosurgery

Vancouver, Washington, 98686, United States

Location

Results Point of Contact

• Title: Pamela Fairchild
• Organization: Rebound Research and Education Foundation.

pfairchild@reboundmd.com

3604498728

Study Officials

• Todd Borus, MD

  Rebound Orthopedics and Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: July 13, 2023
• Results First Posted: July 13, 2023

Record last verified: 2022-08

Locations

US (1)