Arthritis of KneeNCT01505452
Study of Surgical Technique With Use of Single-radius Prosthesis in Total Knee Replacement
An observational study of Arthritis of Knee, run by Athens Orthopedic Clinic, P.A. at 2 sites in United States.
Trial summary
The purpose of this study is to clinically demonstrate a phenomenon of measurement error that can occur during placement of a specific type of total knee replacement prosthesis (single radius femoral component) using a certain type of surgical technique (flexion/extension gap balancing). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis of Knee
- How many people
- 43 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Feb 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinic based population (patients undergoing total knee replacement at an orthopedic surgery clinic).
Who may be able to join
- Scheduled to undergo primary total knee arthroplasty performed by the principal investigator
- Use of a single radius posterior-stabilized TKA prosthesis is planned
- Spinal anesthetic is planned
- Diagnosis of osteoarthritis
- Has normal knee ligaments with no history of previous injury or surgery to ligaments, or other pathologic condition
- Has at least 100 degrees knee flexion preoperatively (measured by long goniometer)
- Gives valid informed consent
- Age 18 years or older
Who cannot join
- Patient receives general anesthetic
- Diagnosis other than osteoarthritis (e.g., rheumatoid arthritis, avascular necrosis, post-traumatic arthritis)
- History of any prior knee ligament injury, or any surgery to ligaments
- Any connective tissue disease affecting integrity of the ligaments (must have normal ligaments)
- History of long bone fracture in the affected leg
- Flexion contracture that would interfere with ability to establish extension gap reliably (judgment of investigator)
Show all 16Show fewer
- Maximum pre-operative knee flexion is less than 100 degrees.
- Patient is non-ambulatory
- Any preclusion or inability to use navigation
- Treatment with single radius posterior stabilized TKA prosthesis is not indicated
- Participation is not in best interest of patient for any reason
- Cannot or does not give valid informed consent
- Female patient who is currently pregnant
- Age less than 18 years
- Body mass index greater than 40 kg/(m*m)
- Incarcerated
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Athens Orthopedic Clinic
Athens, Georgia, 30606
St Mary's Hospital
Athens, Georgia, 30606
About this study
Official title: Translational Error in Flexion-extension Gap Balancing With Singe Radius Total Knee Arthroplasty
The purpose of this study is to clinically demonstrate a phenomenon of measurement error that can occur during placement of a specific type of total knee replacement prosthesis (single radius femoral component) using a certain type of surgical technique (flexion/extension gap balancing).
- Conditions
- Arthritis of Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in varus/vagus laxity of the knee joint measured with the knee positioned at a 90 degree angle with posteriorly stabilized vs. cruciate retaining trails in place.
During the surgical procedure each participant will undergo measurement of varus/valgus laxity (in degrees) at 90 degrees knee flexion using both types of trial implants in sequence. We will evaluate whether the difference of varus/valgus laxity between the two surgical conditions is correlated to change in anterior/posterior relative position of the tibia (relative to femur) measured between the two conditions. A positive correlation between these two variables (change of position to change of laxity) would demonstrate a potential for measurement error that could occur during surgical procedures if position change of the tibia is not accounted for. All outcomes for this study are measured during the surgical procedure.
Measured: At the time of the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startNov 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis of 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Athens Orthopedic Clinic, P.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Principal investigator, Ormonde M. Mahoney, MD, Athens Orthopedic Clinic, P.A.
- Investigators
- Ormonde M Mahoney, MD, Principal investigator, Athens Orthopedic Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01505452
- Sponsor's protocol ID
- AOC-OM-Stryker-2009-0019
- Status last verified
- Jan 2019
- First submitted
- 4 Jan 2012
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Error in Flexion-extension Gap Balancing With Singe Radius Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01505452
- Acronym / sponsor ID
- AOC-OM-Stryker-2009-0019
- Conditions
- Arthritis of Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Athens Orthopedic Clinic, P.A.University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Nov 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 6 Jan 2012 (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.
The purpose of this study is to clinically demonstrate a phenomenon of measurement error that can occur during placement of a specific type of total knee replacement prosthesis (single radius femoral component) using a certain type of surgical technique (flexion/extension gap balancing).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinic based population (patients undergoing total knee replacement at an orthopedic surgery clinic).
Key inclusion criteria (8 listed)
- Scheduled to undergo primary total knee arthroplasty performed by the principal investigator
- Use of a single radius posterior-stabilized TKA prosthesis is planned
- Spinal anesthetic is planned
- Diagnosis of osteoarthritis
- Has normal knee ligaments with no history of previous injury or surgery to ligaments, or other pathologic condition
Key exclusion criteria (16 listed)
- Patient receives general anesthetic
- Diagnosis other than osteoarthritis (e.g., rheumatoid arthritis, avascular necrosis, post-traumatic arthritis)
- History of any prior knee ligament injury, or any surgery to ligaments
- Any connective tissue disease affecting integrity of the ligaments (must have normal ligaments)
- History of long bone fracture in the affected leg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in varus/vagus laxity of the knee joint measured with the knee positioned at a 90 degree angle with posteriorly stabilized vs. cruciate retaining trails in place.
Time frame: At the time of the surgical procedure
During the surgical procedure each participant will undergo measurement of varus/valgus laxity (in degrees) at 90 degrees knee flexion using both types of trial implants in sequence. We will evaluate whether the difference of varus/valgus laxity between the two surgical conditions is correlated to change in anterior/posterior relative position of the tibia (relative to femur) measured between the two conditions. A positive correlation between these two variables (change of position to change of laxity) would demonstrate a potential for measurement error that could occur during surgical procedures if position change of the tibia is not accounted for. All outcomes for this study are measured during the surgical procedure.
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 9 Jan 2019.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis of Knee, run by Athens Orthopedic Clinic, P.A. at 2 sites 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 8 inclusion and 16 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Difference in varus/vagus laxity of the knee joint measured with the knee positioned at a 90 degree angle with posteriorly stabilized vs. cruciate retaining trails in place. (time frame: At the time of the surgical procedure). 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 9 Jan 2019.