Comparing Minimal Invasive Surgery en Conventional Total Knee Arthroplasty
NCT ID: NCT02625311
Last Updated: 2015-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
69 participants
INTERVENTIONAL
2004-12-31
2015-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Clinical evaluations, patient questionnaires, X-rays and CT scans were done to compare these two techniques.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
MIS
Minimal invasive surgery for placement total knee prosthesis
surgery method using CR TKP
Operation through minimal invasive surgery or standard open surgery
conventional approach
conventional "open" surgery for placement total knee prosthesis.
surgery method using CR TKP
Operation through minimal invasive surgery or standard open surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
surgery method using CR TKP
Operation through minimal invasive surgery or standard open surgery
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients with Osteo arthritis
* intact collateral ligaments and patella tendon
* patients willing and able to comply with the post-operative schedule
Exclusion Criteria
* 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
45 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Maastricht University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MEC04-105
Identifier Type: -
Identifier Source: org_study_id