Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty (MIS)

A Prospective Comparative Randomized International Multicenter Study Comparing MIS Computer Navigated Total Knee Arthroplasty vs Conventional Computer Navigated Total Knee Arthroplasty

Randomized clinical trial comparing minimal invasive operating technique to conventional operating technique for placement of total knee prosthesis.

Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Procedure: surgery method using CR TKP

Detailed Description

Study executed with 3 centers and 69 patients.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patient requiring Total Knee Arthroplasty (TKA)
• patients with Osteo arthritis
• intact collateral ligaments and patella tendon
• patients willing and able to comply with the post-operative schedule

Exclusion Criteria:

• patients who require a revision TKA
• patients with TKA contralateral knee within 6 months with bad outcomes
• patients who need a TKA on contralateral side within 2 years
• intraoperative resurfacing of patella
• intraoperative eversion of patella
• patients who had prior procedure of involved knee such as high tibial osteotomy, cruciate ligament recontruction, knee fusion or patellectomy
• BMI > 30
• patients with fixed flexion contracture> 15 degrees
• patients with deformity greater than 20 degrees of varus or 15 degrees of valgus
• Patient with Mediolateral stability > 10 degrees patient with active or suspected malignancy
• patient with Rheumatoid arthritis
• patient with systemic disease that would effect subject's wellfare or overall outcome of the study
• patient with other severe concurrent joint involvement which can effect their outcome
• patients with an immobile hip
• patient with a history of Pulmonary embolism or Deep venous thrombosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MIS; Minimal invasive surgery for placement total knee prosthesis	Procedure: surgery method using CR TKP; Operation through minimal invasive surgery or standard open surgery; Other Names: Cruciate retaining (CR total knee prosthesis (TKP) Stryker
ACTIVE_COMPARATOR: conventional approach; conventional "open" surgery for placement total knee prosthesis.	Procedure: surgery method using CR TKP; Operation through minimal invasive surgery or standard open surgery; Other Names: Cruciate retaining (CR total knee prosthesis (TKP) Stryker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion	measurement of flexion and extension in degrees	pre-op vs post-op until 5 years post-op
blood loss	measurement of milliliters blood loss during the first 24 hours after surgery	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient questionnaire	WOMAC pain and function score	pre-op vs post-op until 5 year post operative
chair rise and stair climb test	Ability of patient rise from chair and climb stairs, amount of pain on VAS 1-10 does the patient have during these activities	pre-op vs post-op until 5 years post operative

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center

Publications and helpful links

General Publications

• Feczko P, Engelmann L, Arts JJ, Campbell D. Computer-assisted total knee arthroplasty using mini midvastus or medial parapatellar approach technique: A prospective, randomized, international multicentre trial. BMC Musculoskelet Disord. 2016 Jan 13;17:19. doi: 10.1186/s12891-016-0872-7.

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (ACTUAL): February 1, 2011
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: November 30, 2015
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (ESTIMATE): December 9, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): December 9, 2015
• Last Update Submitted That Met QC Criteria: December 8, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: MEC04-105