Minimally Invasive Knee Replacement Outcomes (MIKRO) Study

NCT00633113 | Completed DMC

• 1 other identifier: MIKRO
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

\- Medial Parapatellar Arthrotomy (MPPA) technique

Procedure: MPPA

2

ACTIVE COMPARATOR

\- Subvastus (SV) technique

Procedure: SV

Interventions

MPPA PROCEDURE

\- Medial Parapatellar Arthrotomy

1

SV PROCEDURE

\- Subvastus Technique

2

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

15-phenyl-beta-methylpentadecanoic acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ivan M Tomek, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 11, 2008
• Study Start: November 1, 2007
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

US (1)