The relation between pre-operative parameters and patient satisfaction after Total Knee Arthroplasty

Conditions: Patients who require TKA as a result of arthritis

Registration Number: NL-OMON28068

Lead Sponsor: Materialise N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

•Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved
•Body-mass-index (BMI) below 35 kg/m2
•High need to obtain pain relief and improve function
•Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations
•Ability to work with a mobile device for tele-rehabilitation
•Consent form read, understood and signed by patient

Exclusion Criteria

•Correction or revision of previous knee joint replacement procedure
•Patients selected for a posterior stabilized implant type
•Failure of previous joint replacement
•Patients with severe pre-operative varus or valgus deformity greater than or equal to 15 degrees
•BMI greater than or equal to 35 kg/m2
•Not able or willing to undergo MRI and CT scan
•Metal near knee joint (MRI-scan not possible)
•Non-correctable varus axis
•Uncooperative patient or patient with neurological disorders who is incapable of following directions

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to identify correlations between pre-operative parameters and patient satisfaction after TKA surgery. Pre-operative parameters consist of biomechanical parameters, i.e. kinematics, ligament elongations and contact forces over the range of flexion motion, and planning parameters, i.e. bone geometrical dimensions and hip-knee-ankle angle. Patient satisfaction consists of patient reported outcome measures, i.e. KSS and daily pain scores, and objective measures, i.e. activity and video-based evaluation of range of motion and gait.

Secondary Outcome Measures

Name	Time	Method
•To investigate whether the pre-operatively planned implant position corresponds to the post-operative implant position as measured on CT scan<br>•To investigate whether soft tissue releases are necessary during surgery, in which cases and to what extent