Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate and compare the clinical, radiographic (x-ray) and cost effectiveness outcomes (cost relative to risks and benefits) of two different minimally invasive knee joint replacement surgical techniques. The primary study hypothesis is that in comparing total knee replacement performed with the two different surgical techniques that respect four minimally invasive surgery principles (low-profile instrumentation, minimally invasive incision, overall minimal knee surgical intervention), a faster return to function will result when the technique does not incise the tendon.

Detailed Description
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This study does not include financial compensation for treatments involved.

Official Title
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A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: MPPA
* Procedure: SV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of severely symptomatic knee osteoarthritis that has failed non- operative treatment Males and non-pregnant females, 35-85 years of age at the time of surgery ASA class 1 or 2 Procedure will not require computer navigation Patient/Surgeon has not requested another implant Patient has signed an IRB approved study consent form Patient is able and willing to actively participate in post-operative rehabilitation program Patient understands study requirements Patient is willing to comply with follow-up visits and diary documentations Patient is capable of independent ambulation Exclusion Criteria: Skeletal immaturity More than 10 degrees of valgus or varus deformity as measured from a weight bearing AP alignment view Patients with bilateral knee osteoarthritis who are considering a simultaneous bilateral procedure Bone or ligament insufficiency that requires the use of augments or stems, or constrained component Daily pre-operative use of narcotic pain medication Prior knee arthroplasty Patient is a prisoner Patient has had prior tibial tubercle osteotomy Patient's surgical knee would require removal of hardware prior to TKA Patient has < 95 degrees flexion pre-operatively

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>- Medial Parapatellar Arthrotomy (MPPA) technique | Procedure: MPPA<br>* - Medial Parapatellar Arthrotomy<br>|
| Active Comparator: 2<br>- Subvastus (SV) technique | Procedure: SV<br>* - Subvastus Technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome: Includes cost-effectiveness of the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups; EQ-5D, SF-12; radiographic assessment using Knee Society Radiographic Assessment. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Arthroplasty, Minimally Invasive Knee Replacement, Knee Osteoarthritis, Cost effectiveness minimally invasive knee surgery