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

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Procedure: surgery method using CR TKP

Study type: Interventional

Funder types: Other

Identifiers

NCT02625311

MEC04-105

Details and patient eligibility

About

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.

Full description

Study executed with 3 centers and 69 patients.

Enrollment: 69 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

69 participants in 2 patient groups

MIS

Experimental group

Description:

Minimal invasive surgery for placement total knee prosthesis

Treatment:

Procedure: surgery method using CR TKP

conventional approach

Active Comparator group

Description:

conventional "open" surgery for placement total knee prosthesis.

Treatment:

Procedure: surgery method using CR TKP