Status:
COMPLETED
Minimally Invasive Knee Replacement Outcomes (MIKRO) Study
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Zimmer Biomet
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
35-85 years
Phase:
NA
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 j...
Detailed Description
This study does not include financial compensation for treatments involved.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00633113
Start Date
November 1 2007
End Date
September 1 2012
Last Update
April 29 2013
Active Locations (1)
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1
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756