Total Knee Arthroplasty Guidance Systems Study

NCT02830997 | Completed FDA Device

• 1 other identifier: AOC-OM-St-2015-026
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In total knee replacement operations, the surgeon uses techniques and instruments to guide the operation and ensure that all parts of the prosthesis (the artificial knee surfaces) are placed into the correct position. There are many techniques a surgeon can use to achieve accuracy in the operation. This study will compare the Principal Investigator's present precision-guided technique and instrumentation methods with a newly developed technique that uses a computer-based stereotactic guidance system. The purposes of the study are: 1.) to learn whether the use of the different guidance systems results in differences of accuracy of the placement of the prosthesis; 2.) to compare the length of time it takes an experienced joint replacement specialist to complete the operation using the different guidance systems; 3.) to learn whether there are advantages of either system in terms of the function and recovery of patients over the first year after surgery; and, 4.) to provide the manufacturer of the stereotactic guidance system with feedback on the technical ease of use and workflow ease of the system which may be used for training and education purposes and/or for planning further refinements to the system. The study will enroll up to 150 patients from Athens Orthopedic Clinic over 2 to 3 years.

Conditions

Osteoarthritis, Knee; Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Accuracy of total knee arthroplasty component placement in the coronal, axial, and sagittal planes measured by computed tomography scan

  Difference of coronal alignment between pre-operative plan and resultant alignment measured by post-operative CT scan

  2 months post-operatively

Secondary Outcomes (4)

• Skin-to-skin surgical time in minutes

  measured during the surgical operation

• Patient reported physical function measured by 2011 Knee Society Scoring System

  2, 4, 6, and 12 months post-operatively

• Patient reported health related quality of life measured by the Veteran's Rand 12-item Health Survey

  2, 4, 6, and 12 months post-operatively

• Patient reported satisfaction measured by 2011 Knee Society Scoring System

  2,4,6, and 12 months post-operatively

Study Arms (2)

Conventional guidance

The conventional guidance will undergo TKA surgery with use of the Investigator's usual precision guided technique based on conventional instrumentation (mechanical and simple computer-assisted guidance techniques). For participants of the conventional guidance arm, the Investigator will employ the established technique he currently employs for all routine TKA procedures and would employ if the patient were not a participant in the study.

Stereotactic guidance

The stereotactic guidance group will undergo their TKA surgery with use of a stereotactic guidance system.

Device: Stereotactic guidance system

Interventions

Stereotactic guidance system DEVICE

Also known as: Stryker robotic arm system (Mako)

Stereotactic guidance

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The source of participants for this study will be the pool of patients who have already elected to undergo TKA surgery under the Principal Investigator's care and have requested a surgery date with the scheduling nurse. The study population will consist of men and women aged 45 years and older selected from this source population at the discretion of the investigator who meet the eligibility criteria and voluntarily enroll in the study. There will be no solicitation of potential participants from the community or seeking of referrals for the purposes of recruitment into this study.

You may qualify if:

• Scheduled to undergo unilateral primary total knee arthroplasty performed by the Principal Investigator at St. Mary's Hospital
• Use of Triathlon® CR Total Knee System is indicated
• Spinal anesthetic is planned
• Age 45 years or greater
• Body mass index (BMI) ≤ 40 kg/m2
• Patient is willing and able to undergo postoperative follow-up requirements and self evaluations
• Patient gives valid informed consent and signs the approved Informed Consent and Protected Health Information Use Authorization forms

You may not qualify if:

• Age \< 45 years
• BMI \> 40 kg/m2
• General anesthetic is planned
• Patient scheduled for bilateral total knee arthroplasty, or plans to undergo arthroplasty of another lower extremity joint within one year
• Prior high tibial osteotomy or previous reconstruction to the affected knee including partial arthroplasty
• Neuromuscular disorders, muscular atrophy, or vascular deficiency in the affected limb
• Patient is skeletally immature
• Active infection or suspected infection in or about the joint
• Bone stock that is inadequate to support fixation of the prosthesis
• Collateral ligament insufficiency
• Blood supply limitations, refusal to receive blood transfusion (e.g., religious objection), or medical condition that predisposes patient to increased risk of blood loss (e.g., hemophilia)
• Patient is non-ambulatory
• Female patient is pregnant or lactating
• Patient is incarcerated
• Patient is critically ill or medically frail

Sponsors & Collaborators

• Ormonde M. Mahoney, MD: lead
• Stryker Orthopaedics: collaborator

Study Sites (1)

Athens Orthopedic Clinic, P.A.

Athens, Georgia, 30606, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ormonde M Mahoney, MD

  Athens Orthopedic Clinic, P.A.

  PRINCIPAL INVESTIGATOR

• Tracy L Kinsey, MSPH

  Athens Orthopedic Clinic, P.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 9, 2016
• First Posted: July 13, 2016
• Study Start: July 12, 2016
• Primary Completion: February 6, 2018
• Study Completion: January 5, 2021
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)