Osteoarthritis, KneeNCT02830997
Total Knee Arthroplasty Guidance Systems Study
An observational study of Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Ormonde M. Mahoney, MD at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Arthroplasty, Replacement, Knee
- What is being tested?
- Stereotactic guidance system
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2016to 5 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- Patient with mental or neurological conditions who may be incapable of following instructions
- Previous history of radiation therapy, or other significant lifetime radiation exposure or contraindication to voluntary medical radiation exposure
- 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.
- Cannot or does not give valid informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Athens Orthopedic Clinic, P.A.
Athens, Georgia, 30606
About this study
Official title: A Comparison of Surgical Technologies for Accuracy of Prosthesis Placement and Ease of Surgeon Use in Total Knee Arthroplasty
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.
Read the 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:
- Demographic and background information (age, sex, height, weight, social (occupation/employment), major comorbidity (broadly classified), smoking)
- Patient reported outcome measures (Veteran's Rand 12-item Health Survey; 2011 Knee Society Score)
- Physical Examination (knee range of motion, knee stability)
- Details of the surgical operation
- Operating room workflow details, including skin-to-skin surgical time
- Post-operative disposition
- Radiologic outcomes
- Routine pre- and post-operative radiographs will be reviewed for limb alignment and evidence of prosthesis fixation
- 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'.
- Adverse events
- 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.
- Being tested
- Stereotactic guidance system
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic guidance systemDevice
Also called Stryker robotic arm system (Mako)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Stereotactic guidance system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months post-operatively
Secondary outcomes (4)
Skin-to-skin surgical time in minutes
Skin-to-skin surgical time in minutes
Measured: measured during the surgical operation
Patient reported physical function measured by 2011 Knee Society Scoring System
Patient reported physical function measured by 2011 Knee Society Scoring System
Measured: 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
Patient reported health related quality of life measured by the Veteran's Rand 12-item Health Survey
Measured: 2, 4, 6, and 12 months post-operatively
Patient reported satisfaction measured by 2011 Knee Society Scoring System
Patient reported satisfaction measured by 2011 Knee Society Scoring System
Measured: 2,4,6, and 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study start12 Jul 2016
- Primary completion6 Feb 2018
- Study completion5 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ormonde M. Mahoney, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Sponsor-investigator, Ormonde M. Mahoney, MD, Athens Orthopedic Clinic, P.A.
- Investigators
- Ormonde M Mahoney, MD, Principal investigator, Athens Orthopedic Clinic, P.A.Tracy L Kinsey, MSPH, Study director, Athens Orthopedic Clinic, P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830997
- Sponsor's protocol ID
- AOC-OM-St-2015-026
- Status last verified
- Jul 2022
- First submitted
- 9 Jul 2016
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Surgical Technologies for Accuracy of Prosthesis Placement and Ease of Surgeon Use in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02830997
- Acronym / sponsor ID
- AOC-OM-St-2015-026
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ormonde M. Mahoney, MDUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- 12 Jul 2016 (actual)
- Primary completion
- 6 Feb 2018 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 13 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Demographic and background information (age, sex, height, weight, social (occupation/employment), major comorbidity (broadly classified), smoking)
- Patient reported outcome measures (Veteran's Rand 12-item Health Survey; 2011 Knee Society Score)
- Physical Examination (knee range of motion, knee stability)
- Details of the surgical operation
- Operating room workflow details, including skin-to-skin surgical time
- Post-operative disposition
- Radiologic outcomes
- Routine pre- and post-operative radiographs will be reviewed for limb alignment and evidence of prosthesis fixation
- 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'.
- Adverse events
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: Stereotactic guidance systemThe stereotactic guidance group will undergo their TKA surgery with use of a stereotactic guidance system. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic guidance systemAlso: Stryker robotic arm system (Mako) | Device | Stereotactic guidance |
Primary outcome
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
4 secondary outcomes
Skin-to-skin surgical time in minutes
Time frame: measured during the surgical operation
Patient reported physical function measured by 2011 Knee Society Scoring System
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
Time frame: 2, 4, 6, and 12 months post-operatively
Patient reported satisfaction measured by 2011 Knee Society Scoring System
Time frame: 2,4,6, and 12 months post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ormonde M Mahoney, MD principal investigator
Athens Orthopedic Clinic, P.A.
Tracy L Kinsey, MSPH study director
Athens Orthopedic Clinic, P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Arthroplasty, Replacement, Knee, run by Ormonde M. Mahoney, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.