Clinical trial NCT00633113: Minimally Invasive Knee Replacement Outcomes (MIKRO) Study
Official title: A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Total Knee Arthroplasty
Minimally Invasive Knee Replacement
Knee Osteoarthritis
Cost effectiveness minimally invasive knee surgery
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2008-03-11
Enrollment: 131
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: This study does not include financial compensation for treatments involved.

Eligibility criteria: 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

Primary outcomes:
measure: Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score.
timeFrame: 5 years
Secondary outcomes:
measure: 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.
timeFrame: 5 years
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Ivan M Tomek, MD
role: PRINCIPAL_INVESTIGATOR
References: