Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

Completed · Not applicable

Conditions studied: Knee Osteoarthritis

In brief

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.

Key facts

Study ID

NCT00633113

Run by

Dartmouth-Hitchcock Medical Center

People needed

131

Starts

2007-11-01

Expected to finish

2012-09-01

Last updated by the study team

2013-04-29

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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