Prospective Functional, Gait, and Outcome Comparison Study of Medial Pivot
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- LifeBridge Health
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in Anterior/Posterior Knee Translation
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Patients with degenerative joint disease can effectively be treated with a primary total knee replacement to reduce pain and improve function in their daily lives. Theoretically, achievement of normal knee motion using a medial pivot design in total knee replacements can be recreated in comparison to single radius designs, which could lead to an improvement in post-surgical outcomes and satisfaction with the procedure. The aim of this study is to compare two types of implant designs (medial pivot and single radius) in a total knee replacement using clinical outcomes, patient reported outcomes, and overall function assessed by a specialized gait laboratory.
Detailed Description
This is a single center, cohort study in 100 adult subjects undergoing primary total knee arthroplasty that will receive one of the two total knee device systems. Primary total knee replacement is an effective treatment for relieving pain and improving function for patients with degenerative joint disease. Recently, design of knee implants in a total knee replacement have received increased interest, particularly the medial pivot designs. Single-radius implants are designed to minimize instability throughout the functional range of movement. Medial pivot total knee designs theoretically recreate more normal knee motion when compared to single radius designs. Both implant designs are commonly used for total knee replacements. Outcomes of TKA are evaluated by multiple methods including implant/device survivorship, radiographic assessments, clinical examinations, and patient reported outcome measures (PROMS). Laboratory based gait analysis performed at a specialized research facility is not commonly conducted in patients with positive outcomes post-surgery as this is associated with high cost. There is currently not enough research comparing these two designs directly. Research is required to determine which design may provide better clinical outcomes and satisfaction with the procedure. In addition to your normal standard clinical care, there will be scheduled pre-operative, operative, 6-week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visits.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is male or non-pregnant female aged between 18 and 75 years of age.
- •Subject is willing to provide informed consent to participate in the research study.
- •Subject is indicated for a primary total knee arthroplasty (TKA) based on the approved labeling of knee implant, either a medial pivot or single radius design, specifically: MicroPort Evolution Medial-Pivot Knee System, Cruciate Retaining (CS) or Stryker Triathlon Tritanium (CS)
- •Subject does not have a history of previous prosthetic replacement device on the operative knee.
- •Subject is currently ambulating and does not have a condition on the contralateral limb in the opinion of the investigator that would interfere with the gait laboratory evaluations.
- •Subject is willing and able to comply with the schedule of events for the study and is available to return to the clinic for all required follow-up visits.
Exclusion Criteria
- •Subject has a Body Mass Index (BMI) \>40
- •Subject has a diagnosis of avascular necrosis or inflammatory arthritis.
- •Subject has any mental or neuromuscular disorder that would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- •Subject is a prisoner
- •Subject has any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
Outcomes
Primary Outcomes
Change in Anterior/Posterior Knee Translation
Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
This parameter will be measured (in mm) and analyzed using the KneeKG system during incline and decline walking.
Change in Quadriceps Muscle Strength
Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
This parameter will be measured (in lbs/in) using a dynamometer for quadricep muscle strength assessment.
Change in Quadriceps Lag
Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Quadriceps lag will be measured (in degrees) in both the sitting and supine positions.
Change in Initial Peak Loading Force
Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
This parameter will be measured (in N) and analyzed using the KneeKG system during normal walking.
Change in Five Times Sit to Stand Test
Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
This parameter will be measured in seconds and will collect the amount of time it takes a patient to transfer from a seated to a standing position and back to sitting five times.
Change in Knee Mechanics
Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Knee flexion/extension, varus/valgus, and internal/external rotation will be measured (in degrees) and analyzed using the KneeKG system during incline and decline walking.
Change in Timed up and Go Test (TUG)
Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
This parameter will be measured in seconds and requires a patient to rise from a chair walk three meters and return to the chair again as quickly as possible.
Change in Active and Passive Range of Motion
Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
Active and passive range of motion will be measured (in degrees) using a goniometer.
Change in Single Limb Stance Test for Both Knees
Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
This parameter will be measured in seconds and will collect the amount of time a patient is able to stand unassisted on one leg.
Change in Timed Ascent and Descent of One Flight of Stairs Test
Time Frame: Pre-operative; Post-operative - 3 month and 12 month follow-up visit
This parameter will be measured in seconds and will collect the amount of time it takes a patient to ascend and descend one flight of stairs (8-14 steps).
Secondary Outcomes
- Change in Knee Society Score (KSS) Short Form(Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit)
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)(Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit)
- Implant Survivorship(Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit)
- Post-surgical Complications(Operative visit; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit)
- Change in Forgotten Joint Score FJS(Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit)
- Evidence of Osteolysis(Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS-10)(Pre-operative; Post-operative - 6 week, 6 month, 12 month, 24 month, 36 month, and 60 month follow-up visit)