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

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MPPA
SV
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Total Knee Arthroplasty, Minimally Invasive Knee Replacement, Knee Osteoarthritis, Cost effectiveness minimally invasive knee surgery

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

- Medial Parapatellar Arthrotomy (MPPA) technique

- Subvastus (SV) technique

Outcomes

Primary Outcome Measures

Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score.

Secondary Outcome Measures

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.

Full Information

First Posted
March 4, 2008
Last Updated
April 25, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT00633113
Brief Title
Minimally Invasive Knee Replacement Outcomes (MIKRO) Study
Acronym
MIKRO
Official Title
A Randomized, Prospective, Blinded Clinical Trial Comparing Two Total Knee Replacement Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Zimmer Biomet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Total Knee Arthroplasty, Minimally Invasive Knee Replacement, Knee Osteoarthritis, Cost effectiveness minimally invasive knee surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
- Medial Parapatellar Arthrotomy (MPPA) technique
Arm Title
2
Arm Type
Active Comparator
Arm Description
- Subvastus (SV) technique
Intervention Type
Procedure
Intervention Name(s)
MPPA
Intervention Description
- Medial Parapatellar Arthrotomy
Intervention Type
Procedure
Intervention Name(s)
SV
Intervention Description
- Subvastus Technique
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan M Tomek, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

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