Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

NCT ID: NCT00633113

Last Updated: 2013-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2012-09-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

\- Medial Parapatellar Arthrotomy (MPPA) technique

Group Type: ACTIVE_COMPARATOR

MPPA

Intervention Type: PROCEDURE

\- Medial Parapatellar Arthrotomy

2

\- Subvastus (SV) technique

Group Type: ACTIVE_COMPARATOR

SV

Intervention Type: PROCEDURE

\- Subvastus Technique

Interventions

MPPA

\- Medial Parapatellar Arthrotomy

Intervention Type: PROCEDURE

SV

\- Subvastus Technique

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan M Tomek, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

MIKRO

Identifier Type: -

Identifier Source: org_study_id