Osteoarthritis of the KneeNCT02228538
Total Knee Arthroplasty Functional Outcomes Study Research Design
An observational study of Osteoarthritis of the Knee, run by Restor3D at 1 site in United States.
Trial summary
The purpose of this study is to obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Total knee arthroplasty patients
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Sep 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Total knee arthroplasty patients
Who may be able to join
- Patient is male or non-pregnant female age 18 years or older at time of study
- Patient is a candidate for a total knee arthroplasty
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation
Who cannot join
- Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopedic surgeon
- Patients who have had any previous lower extremity procedure
- Patients with a BMI greater than or equal to 40
- Patients with an active infection within the affected knee joint
- Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
- Patients diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's disease)
Show all 10Show fewer
- Patients immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
- Patients with a known sensitivity to device materials
- Non-English speaking patients
- Patient is a prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
About this study
The purpose of this study is to obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty.
Read the detailed description
This study aims to use up to 75 patients at 3 centers to determine a baseline short-term post-operative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Total knee arthroplasty patients
- Keywords
- total knee arthroplasty, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplasty patientsDevice
Also called knee replacement, joint replacement
ConforMIS iTotal (CR) knee implant system \& off-the-shelf standard knee implant system from various manufacturers
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty patients | ConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers Receives: Device: Total knee arthroplasty patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Functional Tests at 6 weeks
Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
Measured: 6 weeks post-op
Timed Functional testing at 6 months
Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
Measured: 6 months post op
Timed Functional Testing at 1 year
Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
Measured: 1 year post-op
Secondary outcomes (3)
Outcome questionnaires at 6 weeks
Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.
Measured: 6 weeks post-op
Outcome questionnaires at 6 months
Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.
Measured: 6 months post-op
Outcome questionnaires at 1 year
Assess knee pain and function scores over time. Comparing questionnaire scores from pre-op to post op of patients.
Measured: 1 year post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completionSep 2016
Why it stopped: Not enough subject participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restor3D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ochsner Health System
- Responsible party
- Sponsor
- Investigators
- Deryk Jones, MD, Principal investigator, Ochsner Heath System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228538
- Sponsor's protocol ID
- 13-003
- Status last verified
- Oct 2023
- First submitted
- 5 Jun 2014
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Arthroplasty Functional Outcomes Study Research Design
- ClinicalTrials.gov ID
- NCT02228538
- Acronym / sponsor ID
- 13-003
- Conditions
- Osteoarthritis of the Knee
- Keywords
- total knee arthroplasty, osteoarthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough subject participation
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Restor3DIndustry (pharma, biotech, devices)
- Collaborators
- Ochsner Health System
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Aug 2014 (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 obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty.
Detailed description
This study aims to use up to 75 patients at 3 centers to determine a baseline short-term post-operative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty patients | – | Device: Total knee arthroplasty patientsConforMIS iTotal (CR) knee implant system and off-the-shelf knee implant systems from various manufacturers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Total knee arthroplasty patients
Key inclusion criteria (3 listed)
- Patient is male or non-pregnant female age 18 years or older at time of study
- Patient is a candidate for a total knee arthroplasty
- Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation
Key exclusion criteria (10 listed)
- Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopedic surgeon
- Patients who have had any previous lower extremity procedure
- Patients with a BMI greater than or equal to 40
- Patients with an active infection within the affected knee joint
- Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
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 |
|---|---|---|
| Total knee arthroplasty patientsAlso: knee replacement, joint replacementConforMIS iTotal (CR) knee implant system \& off-the-shelf standard knee implant system from various manufacturers | Device | Total knee arthroplasty patients |
Primary outcome
Timed Functional Tests at 6 weeks
Time frame: 6 weeks post-op
Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
Timed Functional testing at 6 months
Time frame: 6 months post op
Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
Timed Functional Testing at 1 year
Time frame: 1 year post-op
Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
3 secondary outcomes
Outcome questionnaires at 6 weeks
Time frame: 6 weeks post-op
Outcome questionnaires at 6 months
Time frame: 6 months post-op
Outcome questionnaires at 1 year
Time frame: 1 year post op
Results and safety
The study was stopped early (reason given: Not enough subject participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
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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.
Deryk Jones, MD principal investigator
Ochsner Heath System
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 of the Knee, run by Restor3D 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 3 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: stopped early, as of the sponsor's last update on 25 Oct 2023. 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 was stopped early (reason given: Not enough subject participation). Results are not available in the source record.
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?
Timed Functional Tests at 6 weeks (time frame: 6 weeks post-op). The study lists 3 primary outcomes in all. 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 25 Oct 2023.