OsteoarthritisNCT03387839
Antero-Posterior Knee Stability
An observational study of Osteoarthritis and Total Knee Arthroplasty, run by David F. Scott, MD at 1 site in United States.
Trial summary
A retrospective one-time evaluation of total knee patients one year or more postoperative, to compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and clinical outcomes. Multiple implant brand/models will be included in the study. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis, Total Knee Arthroplasty, Stability
- What is being tested?
- Stress X-Ray
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Dec 2017
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Internal database of prior total knee replacement patients.
Who may be able to join
- Patients willing to sign the informed consent.
- Patients able to comply with study requirements including stress x-rays and self-evaluations.
- Male and non-pregnant females ages 21 - 80 years of age at the time of surgery.
- Patients who have undergone a primary total knee replacement, are one year or greater postoperative, and are not having any evidence of failure of their implants.
- Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- Patients with intact collateral ligaments.
- Range of motion within five degrees of full extension and a minimum of 120 degrees of flexion.
Who cannot join
- Patients with inflammatory arthritis.
- Patients that are morbidly obese, body mass index (BMI) > 40.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
- Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers.
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- Patients bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
- Patients with knee fusion to the affected joint.
- Patients with an active or suspected latent infection in or about the knee joint.
- Patients that are prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spokane Joint Replacement Center
Spokane, Washington, 99218
About this study
Official title: Antero-Posterior Knee Stability With Medial-Pivot, Cruciate-Substituting, and Posterior-Stabilized Total Knee Arthroplasty: A Retrospective Study
A retrospective one-time evaluation of total knee patients one year or more postoperative, to compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and clinical outcomes. Multiple implant brand/models will be included in the study.
- Being tested
- Stress X-Ray
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress X-RayOther
Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
| Study group | Role | What they receive |
|---|---|---|
| Medial-Pivot Knee Prosthesis | Not described Receives: Other: Stress X-Ray | |
| Posterior-Stabilized Knee Prosthesis | Not described Receives: Other: Stress X-Ray | |
| Cruciate-Stubstituting Knee Prosthesis | Not described Receives: Other: Stress X-Ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of antero-posterior stability of the knee with stress x-rays.
Antero-posterior stability of the knee will be measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion. Stress x-rays will be obtained during a single visit for subjects 1 year or greater post-operatively.
Measured: 1 year post-operative
Secondary outcomes (3)
Knee Society Score (KSS)
Clinical outcomes will be evaluated via the Knee Society Score (KSS) obtained during a single visit for subjects 1 year or greater post-operatively. The KSS is subdivided into a Knee Assessment score which rates only the knee joint itself, and a Functional Assessment score which rates the subject's ability to walk and climb stairs. Both scores range from 0-100, with a higher score indicating a better outcome.
Measured: 1 year post-operative
Lower Extremity Activity Scale (LEAS)
Clinical outcomes will be evaluated via the Lower Extremity Activity Scale (LEAS) obtained during a single visit for subjects 1 year or greater post-operatively. The LEAS scale range is 1-18, with a higher value indicating a higher level of activity.
Measured: 1 year post-operative
Forgotten Joint Score (FJS)
Clinical outcomes will be evaluated via the Forgotten Joint Score (FJS) obtained during a single visit for subjects 1 year or greater post-operatively. The FJS total score range is 0-100, with higher scores indicating a higher degree of "forgetting" the artificial joint, that is, a lower degree of awareness.
Measured: 1 year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study startJan 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- David F. Scott, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David F. Scott, MD, Spokane Joint Replacement Center
- Investigators
- David F Scott, MD, Principal investigator, Spokane Joint Replacement Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387839
- Sponsor's protocol ID
- SJRC-AP-Stability
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 2 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antero-Posterior Knee Stability With Medial-Pivot, Cruciate-Substituting, and Posterior-Stabilized Total Knee Arthroplasty: A Retrospective Study
- ClinicalTrials.gov ID
- NCT03387839
- Acronym / sponsor ID
- SJRC-AP-Stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- David F. Scott, MDUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 2 Jan 2018 (actual)
- 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.
A retrospective one-time evaluation of total knee patients one year or more postoperative, to compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and clinical outcomes. Multiple implant brand/models will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medial-Pivot Knee Prosthesis | – | Other: Stress X-Ray |
| Posterior-Stabilized Knee Prosthesis | – | Other: Stress X-Ray |
| Cruciate-Stubstituting Knee Prosthesis | – | Other: Stress X-Ray |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Internal database of prior total knee replacement patients.
Key inclusion criteria (7 listed)
- Patients willing to sign the informed consent.
- Patients able to comply with study requirements including stress x-rays and self-evaluations.
- Male and non-pregnant females ages 21 - 80 years of age at the time of surgery.
- Patients who have undergone a primary total knee replacement, are one year or greater postoperative, and are not having any evidence of failure of their implants.
- Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
Key exclusion criteria (10 listed)
- Patients with inflammatory arthritis.
- Patients that are morbidly obese, body mass index (BMI) > 40.
- Patients that have had a high tibial osteotomy or femoral osteotomy.
- Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- Patients with a systemic or metabolic disorder leading to progressive bone deterioration.
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 |
|---|---|---|
| Stress X-RayAntero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion | Other | Cruciate-Stubstituting Knee Prosthesis, Medial-Pivot Knee Prosthesis, Posterior-Stabilized Knee Prosthesis |
Primary outcome
Measurement of antero-posterior stability of the knee with stress x-rays.
Time frame: 1 year post-operative
Antero-posterior stability of the knee will be measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion. Stress x-rays will be obtained during a single visit for subjects 1 year or greater post-operatively.
3 secondary outcomes
Knee Society Score (KSS)
Time frame: 1 year post-operative
Lower Extremity Activity Scale (LEAS)
Time frame: 1 year post-operative
Forgotten Joint Score (FJS)
Time frame: 1 year post-operative
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 2 Jan 2018.
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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.
David F Scott, MD principal investigator
Spokane Joint Replacement Center
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 and Total Knee Arthroplasty, run by David F. Scott, 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 10 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 2 Jan 2018. 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?
Measurement of antero-posterior stability of the knee with stress x-rays. (time frame: 1 year post-operative). 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 2 Jan 2018.