Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

This study has been completed.
Sponsor:
Collaborator:
Zimmer, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00633113
First received: March 4, 2008
Last updated: April 25, 2013
Last verified: April 2013

March 4, 2008
April 25, 2013
November 2007
September 2012   (final data collection date for primary outcome measure)
Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score. [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00633113 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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: 3.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Minimally Invasive Knee Replacement Outcomes (MIKRO) Study
A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques

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.

This study does not include financial compensation for treatments involved.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Procedure: MPPA
    - Medial Parapatellar Arthrotomy
  • Procedure: SV
    - Subvastus Technique
  • Active Comparator: 1
    - Medial Parapatellar Arthrotomy (MPPA) technique
    Intervention: Procedure: MPPA
  • Active Comparator: 2
    - Subvastus (SV) technique
    Intervention: Procedure: SV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
131
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
35 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00633113
MIKRO
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Zimmer, Inc.
Principal Investigator: Ivan M Tomek, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP