Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty

NCT02625311 | Completed Phase 4

• 1 other identifier: MEC04-105
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• patient questionnaire

  pre-op vs post-op until 5 year post operative

• chair rise and stair climb test

  pre-op vs post-op until 5 years post operative

Study Arms (2)

MIS

EXPERIMENTAL

Minimal invasive surgery for placement total knee prosthesis

Procedure: surgery method using CR TKP

conventional approach

ACTIVE COMPARATOR

conventional "open" surgery for placement total knee prosthesis.

Procedure: surgery method using CR TKP

Interventions

surgery method using CR TKP PROCEDURE

Operation through minimal invasive surgery or standard open surgery

Also known as: Cruciate retaining (CR total knee prosthesis (TKP) Stryker

MIS; conventional approach

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Related Publications (1)

• 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.

  PMID: 26762175 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

threonyl-lysyl-proline

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 9, 2015
• Study Start: December 1, 2004
• Primary Completion: February 1, 2011
• Study Completion: January 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-11