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ID
Source
Brief title
Health condition
Patients who require TKA as a result of arthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
• To investigate whether the pre-operatively planned implant position corresponds to the post-operative implant position as measured on CT scan
• To investigate whether soft tissue releases are necessary during surgery, in which cases and to what extent
Background summary
Up to a fifth of primary implant Total Knee Arthroplasty (TKA) patients remains unsatisfied. Patient satisfaction is typically measured using patient reported outcome measures (PROMs). However, these scores are only snapshots and subjective measures of pain and function, and might therefore not fully represent the functional abilities of the patient. More detailed and objective information, such as physical activity and functional range of motion, might be more representative for the abilities of a patient.
Pre-operative parameters, i.e. planning and biomechanical variables, can have a crucial impact on TKA outcome. Specifically knee kinematics, ligament strains and knee loading were determined as important biomechanical variables. To predict post-operative biomechanical parameters based on pre-operative information, biomechanical models can be used. However, it is still unknown how these biomechanical parameters, together with planning parameters, such as geometrical dimensions and implant position, relate to post-operative functional outcome.
Study objective
We hypothesize that a combination of parameters relate to patient satisfaction and are able to differentiate between satisfied and non-satisfied patients. In addition, we hypothesize that the detailed post-operative outcome, as measured using moveUP, results in a stronger correlation with pre-operative parameters than traditional PROM scores.
Study design
Pre-op, Inpatient, 6 W FU, 3 M FU, 6 M FU, 12 M FU
Intervention
moveUP (a CE certified medical device; www.moveup.care) is a digital platform which will be used to provide daily follow up and tele-rehabilitation for patients.
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8619 |
| Other | METC Z : Z2020117 |