Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty

Osteoarthritis, Knee Clinical Trial

— MIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625311
• Other study ID #: MEC04-105
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2015
• Last updated: December 8, 2015
• Start date: December 2004
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Description:

Study executed with 3 centers and 69 patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 2015
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• surgery method using CR TKP
Operation through minimal invasive surgery or standard open surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	range of motion	measurement of flexion and extension in degrees	pre-op vs post-op until 5 years post-op	No
Primary	blood loss	measurement of milliliters blood loss during the first 24 hours after surgery	24 hours after surgery	No
Secondary	patient questionnaire	WOMAC pain and function score	pre-op vs post-op until 5 year post operative	No
Secondary	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	No