Osteoarthritis Clinical Trial
Official title:
Randomized Control Trial Using RSA to Compare the OtisMed Customfit Total Knee Replacement Procedure With Computer Assisted Surgery
Verified date | August 2020 |
Source | Dalhousie University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The OtisMed Custom-fit system for total knee replacements replaces conventional surgical
techniques for templating and intra-operative instrumentation with a preoperative virtual
surgery process that utilizes 3D models of the affected knee from a pre-operative MRI or CT
image. The 3D model of the affected knee is processed with a proprietary algorithm that
virtually alters it to its pre-arthritic state by filling articular defects, removing
osteophytes, and approximating the joint surface. The software then shape matches the knee
replacement femoral and tibial components to the preathritic knee model and aligns the
femoral component to the functional flexion-extension axis of the femur. The final
preoperative step is the machining of custom biocompatible plastic cutting blocks that fit
the arthritic knee. These cutting blocks are used during the knee replacement surgery to
guide the bone cuts so that the replacement components are aligned for the individual
patient.
In this study we propose to compare patients who have received total knee replacement
components with the OtisMed Custom-fit procedure to those who have had the same components
implanted in the conventional manner with Computer Assisted Surgery (CAS). The primary
outcome will be micromotion of tibial and femoral implants at 1 and 2 years after surgery.
Secondary outcomes will include subjective outcomes, accelerometric gait analysis, bone
mineral density, full leg alignment, change in intra-operative frontal plane alignment,
intra-operative deviations from the surgical plan, surgery duration, OR turnover time, number
of instrument pans used, and length of hospital stay.
Status | Completed |
Enrollment | 52 |
Est. completion date | December 2019 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Symptomatic osteoarthritis of the knee indicating surgical intervention 2. Between the ages of 21 and 80 inclusive 3. Ability to give informed consent Exclusion Criteria: 1. Significant co-morbidity affecting ability to ambulate 2. Flexion contracture greater than 15° 3. Extension lag greater than 10° 4. Tibial subluxation greater than 10 mm on standing AP radiograph 5. Prior arthroplasty, patellectomy or osteotomy with the affected knee 6. Lateral or medial collateral ligament instability (> 10° varus/valgus) 7. Leg length discrepancy greater than 10 mm 8. Pregnancy 9. Active or prior infection 10. Morbid Obesity (BMI > 40) 11. Medical condition precluding major surgery 12. Severe osteoporosis or osteopenia 13. Neuromuscular impairment |
Country | Name | City | State |
---|---|---|---|
Canada | Capital District Health Authority | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Dalhousie University |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | RSA migration | 2 years | ||
Secondary | RSA inducible displacement | 1 year | ||
Secondary | Questionnaires | 2 years | ||
Secondary | DEXA | 2 years | ||
Secondary | Gait Analysis (accelerometric) | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04657926 -
A Trial of APPA in the Treatment of Knee Osteoarthritis
|
Phase 2 | |
Completed |
NCT02536833 -
A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects
|
Phase 2 | |
Completed |
NCT03014037 -
Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration
|
N/A | |
Recruiting |
NCT05937542 -
A Qualitative Investigation of CLEAT Participants
|
||
Completed |
NCT03644615 -
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT06061367 -
Muscles Strength and Gait Parameteres After TKA
|
||
Withdrawn |
NCT04976972 -
A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation
|
N/A | |
Completed |
NCT05496205 -
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
|
Phase 1 | |
Completed |
NCT03850665 -
Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach
|
N/A | |
Completed |
NCT02826902 -
Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04402502 -
Dynamic 4DCT to Examine Wrist Carpal Mechanics
|
N/A | |
Completed |
NCT02923700 -
Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial
|
Phase 4 | |
Completed |
NCT04564053 -
Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants
|
Phase 1 | |
Completed |
NCT05070871 -
A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women
|
N/A | |
Not yet recruiting |
NCT05036174 -
Diphenhydramine Ointment for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT02912429 -
Onlay vs. Inlay Patellofemoral Arthroplasty
|
N/A | |
Recruiting |
NCT02666443 -
Low Dose Dexamethasone in Supraclavicular Blocks
|
N/A | |
Active, not recruiting |
NCT02723929 -
Effects of tDCS and tUS on Pain Perception in OA of the Knee
|
||
Withdrawn |
NCT02921594 -
Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties
|
N/A | |
Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A |