Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Procedure: surgery method using CR TKP

• Registration Number: NCT02625311
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Study executed with 3 centers and 69 patients.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2011-02
• Study Completion: 2015-01
• Status Verified: 2015-11
• Study First Submitted: 2015-11-30
• Study First Submitted QC: 2015-12-08
• Last Update Submitted: 2015-12-08
• Study First Posted: 2015-12-09
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIS	surgery method using CR TKP	Minimal invasive surgery for placement total knee prosthesis
conventional approach	surgery method using CR TKP	conventional "open" surgery for placement total knee prosthesis.

Primary Outcome Measures

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

Secondary Outcome Measures

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