Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

NCT00633113 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2013-04-29

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

MPPA

\- Medial Parapatellar Arthrotomy

PROCEDURE

SV

\- Subvastus Technique

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY
  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Ivan M Tomek, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00633113 on ClinicalTrials.gov