Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Total Knee Arthroplasty Guidance Systems Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02830997
Recruitment Status : Enrolling by invitation
First Posted : July 13, 2016
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
Ormonde M. Mahoney, MD, Athens Orthopedic Clinic, P.A.

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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Arthroplasty, Replacement, Knee Device: Stereotactic guidance system

Detailed Description:

The open-label study aims to enroll up to 75 participants into the conventional guidance arm followed by 75 participants into the stereotactic guidance arm, in sequence.

Detailed observational data will be collected during the surgical procedures, and participating patients will be evaluated at prescribed intervals (pre-operatively, and 2,4,6, and 12 months post-operatively) using survey instruments, clinical indicators, and routine radiologic outcomes. Radiologic outcomes will be assessed using standard x-rays that are obtained in the course of normal care for all patients who undergo total knee arthroplasty (TKA). A subset of the first 30 patients enrolled into each treatment arm will, in addition, be asked to voluntarily undergo a computed tomography (CT) scan of the lower extremity (hip, knee, and ankle joints) 8-12 weeks after surgery to measure 3-dimensional accuracy of prosthesis placement and limb alignment.

Data collection will include:

  1. Demographic and background information (age, sex, height, weight, social (occupation/employment), major comorbidity (broadly classified), smoking)
  2. Patient reported outcome measures (Veteran's Rand 12-item Health Survey; 2011 Knee Society Score)
  3. Physical Examination (knee range of motion, knee stability)
  4. Details of the surgical operation
  5. Operating room workflow details, including skin-to-skin surgical time
  6. Post-operative disposition
  7. Radiologic outcomes

    1. Routine pre- and post-operative radiographs will be reviewed for limb alignment and evidence of prosthesis fixation
    2. Post-operative CT scans (hip, knee, ankle) will be used to evaluate accuracy of placement of the TKA prosthesis (femoral and tibial components) and accuracy of limb alignment in the coronal, sagittal, and axial planes. The values measured from the post-operative CT scan will be compared to those of the final intra-operative plan; lack of difference between the two will constitute 'accuracy'.
  8. Adverse events
  9. Patients may optionally participate in an additional clinical follow-up visit at 2 years post-operatively, which will include the patient reported outcome measures, physical, examination, and radiographic examination.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Surgical Technologies for Accuracy of Prosthesis Placement and Ease of Surgeon Use in Total Knee Arthroplasty
Actual Study Start Date : July 12, 2016
Actual Primary Completion Date : February 6, 2018
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
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
Other Name: Stryker robotic arm system (Mako)




Primary Outcome Measures :
  1. Accuracy of total knee arthroplasty component placement in the coronal, axial, and sagittal planes measured by computed tomography scan [ Time Frame: 2 months post-operatively ]
    Difference of coronal alignment between pre-operative plan and resultant alignment measured by post-operative CT scan


Secondary Outcome Measures :
  1. Skin-to-skin surgical time in minutes [ Time Frame: measured during the surgical operation ]
    Skin-to-skin surgical time in minutes

  2. Patient reported physical function measured by 2011 Knee Society Scoring System [ Time Frame: 2, 4, 6, and 12 months post-operatively ]
    Patient reported physical function measured by 2011 Knee Society Scoring System

  3. Patient reported health related quality of life measured by the Veteran's Rand 12-item Health Survey [ Time Frame: 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

  4. Patient reported satisfaction measured by 2011 Knee Society Scoring System [ Time Frame: 2,4,6, and 12 months post-operatively ]
    Patient reported satisfaction measured by 2011 Knee Society Scoring System



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age < 45 years
  2. BMI > 40 kg/m2
  3. General anesthetic is planned
  4. Patient scheduled for bilateral total knee arthroplasty, or plans to undergo arthroplasty of another lower extremity joint within one year
  5. Prior high tibial osteotomy or previous reconstruction to the affected knee including partial arthroplasty
  6. Neuromuscular disorders, muscular atrophy, or vascular deficiency in the affected limb
  7. Patient is skeletally immature
  8. Active infection or suspected infection in or about the joint
  9. Bone stock that is inadequate to support fixation of the prosthesis
  10. Collateral ligament insufficiency
  11. 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)
  12. Patient is non-ambulatory
  13. Female patient is pregnant or lactating
  14. Patient is incarcerated
  15. Patient is critically ill or medically frail
  16. Patient with mental or neurological conditions who may be incapable of following instructions
  17. Previous history of radiation therapy, or other significant lifetime radiation exposure or contraindication to voluntary medical radiation exposure
  18. Has previously participated in or was previously invited to participate in this study during surgery of the contralateral knee, or was previously invited to participate in the opposite treatment arm during surgery of the same knee.
  19. Cannot or does not give valid informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830997


Locations
Layout table for location information
United States, Georgia
Athens Orthopedic Clinic, P.A.
Athens, Georgia, United States, 30606
Sponsors and Collaborators
Ormonde M. Mahoney, MD
Stryker Orthopaedics
Investigators
Layout table for investigator information
Principal Investigator: Ormonde M Mahoney, MD Athens Orthopedic Clinic, P.A.
Study Director: Tracy L Kinsey, MSPH Athens Orthopedic Clinic, P.A.

Layout table for additonal information
Responsible Party: Ormonde M. Mahoney, MD, Principal Investigator, Athens Orthopedic Clinic, P.A.
ClinicalTrials.gov Identifier: NCT02830997    
Other Study ID Numbers: AOC-OM-St-2015-026
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases