1) To compare gait quality in daily life and challenging gait skills of patients 1 year following cruciate-retaining TKA compared to a healthy, age and gender matched cohort.2) To compare pre- to post-operative cruciate TKA status in quantity and…
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between TKA-CR subjects 1 year post-operatively and healthy controls
on average gait speed from gait bouts identified during 5-7 days continuous
monitoring in real life (free-living).
Secondary outcome
Continous monitoring:
- Quantity of gait bouts/hour
- Peak turning velocity
- Mean stride length
- Mean stride time
- Coefficient of variation of stride time
- Asymmetry of step time
- Coronal trunk range of motion
- Foot strike angle
Challenging gait tasks:
Peturbations:
- Foot placement post-perturbation
- CoM trajectory during the perturbation and subsequent steps
- Margin of stability
- CoP trajectory
- Spatiotemporal gait parameters (step width, step length)
Up/downhill walking:
- Sagittal knee moments
- Knee adduction moments
- Knee joint angles
- Ankle joint moments and angles
- Hip joint moments and angles
- Toe-out angle
- Toe-off angle
- Spatiotemporal gait parameters
Background summary
The main goal of a total knee arthroplasty (TKA) with cruciate retaining (CR)
is to reduce pain and improve mobility during daily life. However, the
effectiveness of this procedure, in terms of improving quality of gait, is
still under debate. In addition, the objective assessment of gait function has
mostly been limited to simple, lab-based tasks. The current study therefore
aims to investigate whether gait function, assessed in real-life conditions as
well as during challenging lab-based tasks, fully recovers 1 year post surgery.
It is expected that, although patients will improve from pre- to post surgery,
their gait will still be impaired in comparison to healthy controls.
Study objective
1) To compare gait quality in daily life and challenging gait skills of
patients 1 year following cruciate-retaining TKA compared to a healthy, age and
gender matched cohort.
2) To compare pre- to post-operative cruciate TKA status in quantity and
quality of gait and turning in daily life (continuous monitoring) and
challenging gait skills.
Study design
Case-control study, with baseline assessment and prospective follow-up at 1 and
2 years post-operatively.
Study burden and risks
The burden of participation to this study is limited to gait assessments
pre-operatively, 1 and 2 year postoperatively at the Sint Maartenskliniek (2-3
hrs each assessment), and around these time points wearing inertial measurement
units embedded in a sock and on the belt for 5 days. Additionally, 2/3
questionnaires will be filled out at these time points (total duration incl.
lab maesurements is 2.5 hours). Radiographic analyses will be performed once to
determine the placement and migration of the knee prosthesis (20 minutes).
Risks are minimal as the subjects will wear a harness attached to the ceiling
to prevent falls during the gait assessment in the clinic. Also, radiation
exposure is minimal during the radiographic measurements. The risks related to
the surgery are minimal, and most importantly, are not higher than the
conventional knee prosthesis placed in our hospital. The measurements at
baseline, 3 and 24 months comprise an addditional burden for the participants
as they are not part of the regular care. Therefore, additional travel expenses
that are related to those measurements will be refunded.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing total knee arthroplasty:
40-80 years old
Non-inflammatory knee osteoarthritis as indicated by radiology
Set to receive a primary total knee arthroplasty
In stable health
Healthy controls:
40-80 years old
In stable health
Exclusion criteria
Patients undergoing total knee arthroplasty:
BMI > 35
Surgery to the study knee
Active infection, systemic infection
Trauma to study knee
Previous knee, hip, or ankle replacement surgery or planned to have one in the
next 24 months
Any musculoskeletal or neurological disease other than osteoarhritis that
impairs gait or balance
Severe damage to any knee ligament other than anterior cruciate ligament
Healthy controls:
Moderate to severe pain in one or both knees, hip or ankle (>4 on items 3-6
form Brief Pain Inventory)
Previous replacement surgery to knee, hip or ankle or planned for future
replacement surgery
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL71606.091.19 |