Skip to main content
OpenTrials
Completed

NCT Number: NCT00633113

Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

This study does not include financial compensation for treatments involved.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MPPA

Procedure
  • Medial Parapatellar Arthrotomy

SV

Procedure
  • Subvastus Technique

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Zimmer Biomet

Registry information

Official study title

A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques

Acronym: MIKRO

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Mar 11, 2008
Registry last updated
Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.