Clinical and Economic Comparison of Robot Assisted Versus Manual Knee Replacement

NCT01705886 | Completed

• 2 other identifiers: MAKO-022015-004
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to document and compare the surgical and after surgery costs, recovery time, and outcomes of two procedure types:

• Robotic assisted surgery replacing one compartment of the knee
• Manual (robot is not used) surgery replacing all three compartments of the knee (total knee replacement) The hypothesis is that robot assisted partial knee replacement is cost effective and provides clinical outcomes that are equivalent to a manual total knee replacement.

Conditions

Knee Arthroplasty

Keywords

Osteoarthritis; Joint Disease; Arthritis; Musculoskeletal Disease; Knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Cost per case at 1 year

  Cost per case for 1 year. The inpatient costs, analgesic use, physical therapy, durable medical equipment, and postoperative visits will be used to calculate the cost at 1 year.

  1 year

Secondary Outcomes (1)

• American Knee Society Knee Score

  1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery

Other Outcomes (11)

• Reduced WOMAC

  1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery

• Knee injury and Osteoarthritis Outcome Score

  1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery

• EQ-5D

  1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year after surgery

Study Arms (1)

Knee Arthroplasty

Patients undergoing knee replacement surgery. This may be a Total Knee Arthroplasty or MAKO® Robot Assisted Medial Knee Arthroplasty. The MAKO® Robot Assisted surgeries use the RESTORIS Multicompartmental Knee System. The total knee arthroplasty uses the Depuy Knee Replacement System or the Stryker® Knee Replacement System.

Procedure: Total Knee Arthroplasty; Procedure: MAKO® Robot Assisted Medial Knee Arthroplasty; Device: RESTORIS Multicompartmental Knee System; Device: Depuy Knee Replacement System; Device: Stryker® Knee Replacement System

Interventions

Total Knee Arthroplasty PROCEDURE

Patients undergoing manual (no robot used) surgery to replace of all 3 compartments of the knee

Also known as: TKA, Total Knee Replacement

Knee Arthroplasty

MAKO® Robot Assisted Medial Knee Arthroplasty PROCEDURE

Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee

Also known as: unilateral knee arthroplasty (UKA)

Knee Arthroplasty

RESTORIS Multicompartmental Knee System DEVICE

The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement.

Also known as: RESTORIS® MCK MultiCompartmental Knee System, FDA 501K number K090763

Knee Arthroplasty

Depuy Knee Replacement System DEVICE

The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.

Knee Arthroplasty

Stryker® Knee Replacement System DEVICE

The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.

Knee Arthroplasty

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and non-pregnant females undergoing knee replacement who are between 21 and 80 years of age with stable health and are willing and able to have physical therapy.

You may qualify if:

• Age, 21-80 years
• Sex, males and females will be included
• BMI less than or equal to 39
• Stable health, the patient would be able to undergo surgery and participate in the follow-up program based on physical examination and medical history
• Patient is willing and able to cooperate in follow-up therapy at Rebound facilities in Vancouver, WA
• Patient has stable and functional collateral ligaments
• Patient or patient's legal representative has signed the Informed Consent form
• Failed non-operative management of their joint disease
• Need to obtain pain relief and improved function
• Moderate or severe pain with either walking or at rest
• Diagnosed with osteoarthritis in one or more compartments of the knee and non-surgical treatment options have failed to provide relief for symptoms
• Patient exhibits preoperative radiographic evidence of joint degeneration that cannot be treated in non-operative fashion

You may not qualify if:

• Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in the study
• Patients with pre-op flexion contracture greater than 10 degrees, overall flexion less than 115 degrees, and varus/valgus greater than 10 degrees
• Patient who is on workmen's compensation
• Patients who are on chronic long acting preoperative narcotic pain medication
• Patients with inflammatory polyarthritis
• Women who are pregnant
• Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes
• Subjects who are currently involved in another clinical study with the exception to an outcomes study
• Patients with a pathology which, in the opinion of the Principal Investigator, will adversely affect healing
• A diagnosed systemic disease that would affect their welfare or the overall outcome of study (i.e. Paget's disease, renal osteodystrophy)
• Patients receiving an isolated patellofemoral UKA,lateral UKA, or bi-compartmental arthroplasty
• Patients with significant medical condition preventing a well-functioning contralateral knee
• cognitively unable to complete study health-related quality of life forms

Sponsors & Collaborators

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

Study Sites (1)

Rebound Orthopedics and Neurosurgery

Vancouver, Washington, 98686, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases; Arthritis; Musculoskeletal Diseases; Osteoarthritis, Knee

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Todd Borus, MD

  Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery

  PRINCIPAL INVESTIGATOR

• Donald Roberts, MD

  Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 12, 2012
• Study Start: October 1, 2012
• Primary Completion: January 1, 2018
• Study Completion: October 1, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

US (1)