Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00633113

Acronym

MIKRO

Enrollment

131

Registered

2008-03-11

Start date

2007-11-30

Completion date

2012-09-30

Last updated

2013-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Total Knee Arthroplasty, Minimally Invasive Knee Replacement, Knee Osteoarthritis, Cost effectiveness minimally invasive knee surgery

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.

Interventions

PROCEDUREMPPA

\- Medial Parapatellar Arthrotomy

PROCEDURESV

\- Subvastus Technique

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

35 Years to 85 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026