Minimally Invasive Knee Replacement Outcomes (MIKRO) Study (MIKRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00633113
Recruitment Status : Completed
First Posted : March 11, 2008
Last Update Posted : April 29, 2013
Zimmer Biomet
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Procedure: MPPA Procedure: SV Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques
Study Start Date : November 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: 1
- Medial Parapatellar Arthrotomy (MPPA) technique
Procedure: MPPA
- Medial Parapatellar Arthrotomy

Active Comparator: 2
- Subvastus (SV) technique
Procedure: SV
- Subvastus Technique

Primary Outcome Measures :
  1. Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00633113

United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Zimmer Biomet
Principal Investigator: Ivan M Tomek, MD Dartmouth-Hitchcock Medical Center

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00633113     History of Changes
Other Study ID Numbers: MIKRO
First Posted: March 11, 2008    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013

Keywords provided by Dartmouth-Hitchcock Medical Center:
Total Knee Arthroplasty
Minimally Invasive Knee Replacement
Knee Osteoarthritis
Cost effectiveness minimally invasive knee surgery

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases