Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Procedure: SV; Procedure: MPPA

• Registration Number: NCT00633113
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-03-04
• Study First Posted: 2008-03-11
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	SV	- Subvastus (SV) technique
1	MPPA	- Medial Parapatellar Arthrotomy (MPPA) technique

Primary Outcome Measures

Name	Time	Method
Primary outcome: clinical outcomes in the Subvastus Total Knee Arthroplasty versus Medial Parapatellar surgical groups, using the Knee Society Score.	5 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States