Osteoarthritis of the KneeNCT00837772
Total Knee Replacement Study Using Standard Cutting Guide vs Otismed MRI Generated Cutting Guide
A study testing Standard cutting guide for TKA and Otismed MRI generated cutting guide for TKA in people with Osteoarthritis of the Knee, run by Phoenix VA Health Care System at 2 sites in United States.
Trial summary
Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are requesting consideration for a total knee replacement. Those who qualify for the knee replacement are informed about the study. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Standard cutting guide for TKA and Otismed MRI generated cutting guide for TKA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2008to Jul 2014
- Phase
- Interventional
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Veterans that are referred to orthopedics surgical clinic for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate.
Who cannot join
- Patients who have undergone osteotomy, had previous healed tibia or femur fractures, previous joint replacement surgery or cannot have an MRI will be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carl T. Hayden VA Medical Center
Phoenix, Arizona, 85012
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, 84148
About this study
Official title: Total Knee Replacement Using Standard Knee Cutting Guides vs Otismed MRI Generated Cutting Guide
Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are requesting consideration for a total knee replacement. Those who qualify for the knee replacement are informed about the study. Those who consent to participate are randomly assigned to either the standard cutting guide or to the new method which is a MRI generated cutting guide called Otismed. All patients have an MRI so both groups will be unaware of which surgical technique is used. All patients receive the usual pre-op care and same type of replacement knee. Follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1 and 2 years. Patients will be informed of which surgical technique they were randomized to at the conclusion of the study.
Read the detailed description
Objective(s):
Primary:
Compare the surgical and clinical outcomes between patients receiving total knee replacement after random assignment to one of two groups:
- surgical procedure with the standard knee cutting guide and
- surgical procedure with the Otismed MRI generated cutting guide
Secondary:
Evaluate the cost benefit ratio related to the two different cutting guide uses.
Research Plan: All patients that are referred to orthopedics, are eligible for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate. Patients will be randomly assigned to either the standard or the Otismed group. All patients will have a MRI of the knee. Patients and the research staff conducting measurements will be blinded to the type of cutting guide used for the surgery.
Methods: The study will be a randomized trial with the patient and data collector blinded to type of cutting guide used for the surgical procedure. The study will be conducted at one site and enrollment goal is 100 patients. Data collection will be done preoperatively and at 4 wks, 3 months, 6 months, one year and two year. Established instruments, the (Western Ontario and McMaster Universities Osteoarthritis Index) Womac and Oxford Knee Score, will be used. Measurements will be done to evaluate ROM (Range Of Motion) and assess post-op recovery. Surgical data and hospitalization data will be used for analysis of costs. Statistical analysis will be used for comparison of the two groups.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- Standard cutting guide for TKA, Otismed MRI generated cutting guide for TKA
- Keywords
- Alignment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard cutting guide for TKADevice
Use of the usual cutting guide for surgical replacement of a diseased knee
Otismed MRI generated cutting guide for TKADevice
Also called Otismed
Use of the customized MRI generated cutting guide for surgical replacement of a diseased knee
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Usual standard cutting guide for TKA (Total Knee Arthroscopy) Receives: Device: Standard cutting guide for TKA |
| Arm 2 | Experimental | Otismed MRI generated cutting guide for TKA Receives: Device: Otismed MRI generated cutting guide for TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient scores on Oxford, Womac, and Knee Society scores
Measured: 4 week, 3 mo. 6 mo. 1 yr. 2 yr.
Secondary outcomes (1)
Leg alignment based on Long Leg CT scans
Measured: Post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startJan 2008
- Primary completionJul 2012
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix VA Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Harold G. Dossett, MD MBA, Principal investigator, Carl T. Hayden VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837772
- Sponsor's protocol ID
- Dossett01
- Status last verified
- Apr 2016
- First submitted
- 3 Feb 2009
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812.
PubMed 24986944Dossett HG, Arthur JR, Makovicka JL, Mara KC, Bingham JS, Clarke HD, Spangehl MJ. A Randomized Controlled Trial of Kinematically and Mechanically Aligned Total Knee Arthroplasties: Long-Term Follow-Up. J Arthroplasty. 2023 Jun;38(6S):S209-S214. doi: 10.1016/j.arth.2023.03.065. Epub 2023 Mar 30.
PubMed 37003458
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Replacement Using Standard Knee Cutting Guides vs Otismed MRI Generated Cutting Guide
- ClinicalTrials.gov ID
- NCT00837772
- Acronym / sponsor ID
- Dossett01
- Conditions
- Osteoarthritis of the Knee
- Keywords
- Alignment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Phoenix VA Health Care SystemUS federal agency
- Study start
- Jan 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Feb 2009 (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.
Patients are referred to the VA orthopedic surgical clinic because of osteoarthritis and are requesting consideration for a total knee replacement. Those who qualify for the knee replacement are informed about the study. Those who consent to participate are randomly assigned to either the standard cutting guide or to the new method which is a MRI generated cutting guide called Otismed. All patients have an MRI so both groups will be unaware of which surgical technique is used. All patients receive the usual pre-op care and same type of replacement knee. Follow-up research visits are scheduled at 4 weeks, 3 and 6 months, and 1 and 2 years. Patients will be informed of which surgical technique they were randomized to at the conclusion of the study.
Detailed description
Objective(s):
Primary:
Compare the surgical and clinical outcomes between patients receiving total knee replacement after random assignment to one of two groups:
- surgical procedure with the standard knee cutting guide and
- surgical procedure with the Otismed MRI generated cutting guide
Secondary:
Evaluate the cost benefit ratio related to the two different cutting guide uses.
Research Plan: All patients that are referred to orthopedics, are eligible for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate. Patients will be randomly assigned to either the standard or the Otismed group. All patients will have a MRI of the knee. Patients and the research staff conducting measurements will be blinded to the type of cutting guide used for the surgery.
Methods: The study will be a randomized trial with the patient and data collector blinded to type of cutting guide used for the surgical procedure. The study will be conducted at one site and enrollment goal is 100 patients. Data collection will be done preoperatively and at 4 wks, 3 months, 6 months, one year and two year. Established instruments, the (Western Ontario and McMaster Universities Osteoarthritis Index) Womac and Oxford Knee Score, will be used. Measurements will be done to evaluate ROM (Range Of Motion) and assess post-op recovery. Surgical data and hospitalization data will be used for analysis of costs. Statistical analysis will be used for comparison of the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Device: Standard cutting guide for TKAUsual standard cutting guide for TKA (Total Knee Arthroscopy) |
| Arm 2 | Experimental | Device: Otismed MRI generated cutting guide for TKAOtismed MRI generated cutting guide for TKA |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All Veterans that are referred to orthopedics surgical clinic for a total knee replacement for osteoarthritis and meet study criteria will be invited to participate.
Key exclusion criteria (1 listed)
- Patients who have undergone osteotomy, had previous healed tibia or femur fractures, previous joint replacement surgery or cannot have an MRI will be excluded.
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 |
|---|---|---|
| Standard cutting guide for TKAUse of the usual cutting guide for surgical replacement of a diseased knee | Device | Arm 1 |
| Otismed MRI generated cutting guide for TKAAlso: OtismedUse of the customized MRI generated cutting guide for surgical replacement of a diseased knee | Device | Arm 2 |
Primary outcome
Patient scores on Oxford, Womac, and Knee Society scores
Time frame: 4 week, 3 mo. 6 mo. 1 yr. 2 yr.
1 secondary outcome
Leg alignment based on Long Leg CT scans
Time frame: Post-op
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 6 Apr 2016.
- Background: PubMed 24986944Dossett HG, Estrada NA, Swartz GJ, LeFevre GW, Kwasman BG. A randomised controlled trial of kinematically and mechanically aligned total knee replacements: two-year clinical results. Bone Joint J. 2014 Jul;96-B(7):907-13. doi: 10.1302/0301-620X.96B7.32812.
- Derived from this study: PubMed 37003458Dossett HG, Arthur JR, Makovicka JL, Mara KC, Bingham JS, Clarke HD, Spangehl MJ. A Randomized Controlled Trial of Kinematically and Mechanically Aligned Total Knee Arthroplasties: Long-Term Follow-Up. J Arthroplasty. 2023 Jun;38(6S):S209-S214. doi: 10.1016/j.arth.2023.03.065. Epub 2023 Mar 30.
- 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.
Harold G. Dossett, MD MBA principal investigator
Carl T. Hayden VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard cutting guide for TKA and Otismed MRI generated cutting guide for TKA in people with Osteoarthritis of the Knee, run by Phoenix VA Health Care System 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 1 inclusion and 1 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 6 Apr 2016. 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?
Patient scores on Oxford, Womac, and Knee Society scores (time frame: 4 week, 3 mo. 6 mo. 1 yr. 2 yr.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00837772, which also lists 2 linked publications.
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 6 Apr 2016.