The primary objective of this study is to identify correlations between pre-operative, i.e. biomechanical and planning, parameters and patient satisfaction after TKA surgery.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoint is to identify correlations between pre-operative, i.e.
biomechanical and planning, parameters and patient satisfaction after TKA
surgery.
Secondary outcome
Alignment of the implant components
Intra-operative soft tissue release
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
The primary objective of this study is to identify correlations between
pre-operative, i.e. biomechanical and planning, parameters and patient
satisfaction after TKA surgery.
Study design
A prospective cohort study design.
Study burden and risks
Instead of the standard physical therapy sessions, the patients will follow a
tele-rehabilitation program using moveUP. TKA surgery will be performed
following the standard of care, using patient-specific instruments. Pre- and
post-operative CT scans are required to be able to reconstruct the exact
implant position after surgery. This will result in an additional exposure to
radiation for the patient (radiation dose for single CT scan: 5.69 mSv).
dr h vd Hoffplein 1
Sittard-Geleen 6162 BG
NL
dr h vd Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
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
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL74117.096.20 |