Total Knee Replacement Study Using Standard Cutting Guide vs Otismed MRI Generated Cutting Guide
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 40 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | January 2008 |
| End Date: | July 2014 |
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.
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.
Objective(s):
Primary:
Compare the surgical and clinical outcomes between patients receiving total knee replacement
after random assignment to one of two groups:
1. surgical procedure with the standard knee cutting guide and
2. 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.
Primary:
Compare the surgical and clinical outcomes between patients receiving total knee replacement
after random assignment to one of two groups:
1. surgical procedure with the standard knee cutting guide and
2. 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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who have undergone osteotomy, had previous healed tibia or femur fractures,
previous joint replacement surgery or cannot have an MRI will be excluded.
We found this trial at
2
sites
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