Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

Knee Osteoarthritis Clinical Trial

— MIKRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633113
• Other study ID #: MIKRO
• Status: Completed
• Phase: N/A
• First received: March 4, 2008
• Last updated: April 25, 2013
• Start date: November 2007
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

This study does not include financial compensation for treatments involved.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• MPPA
- Medial Parapatellar Arthrotomy
• SV
- Subvastus Technique

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Zimmer, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score.		5 years	No
Secondary	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.		5 years	No