To determine:* The occurrence of foot and ankle complaints in patients who are undergoing THA or TKA* The occurrence of radiographic OA of the forefoot, midfoot and ankle in patients who are undergoing THA or TKA* The association between foot and…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assesments will be done at baseline (pre-operatively) and one year
postoperative,
Main outcome parameters are:
- FOAS
- FFI
- extra questions will evaluate multi-joint involvement, foot and ankle
complaints and the presence of comorbidities like polyneuropathy. Also the use
of orthopaedic insoles or modified/custom-made shoes and previous trauma will
be asked
Besides patients will be asked for additional preoperative basic foot and ankle
radiographic examination. These X-rays are done at the preoperative visit and
will consist of an anterior-posterior view, a lateral view and a Mortise-view
of each foot. Foot and ankle X-rays are scored using the Kellgren and Lawrence
score.
Moreover all patients will have physical foot and ankle examination on the
attendance of signs of osteoarthritis by the presences of clavus, hammer-toes
or hallux valgus.
Secondary outcome
Secundary parameters are the LOAS questionnaires:
Knee or hip functioning (HOOS/KOOS and Oxford Hip/Knee Score, Knee instability
questionnaire); physical activity (Sport, hobbies and volunteering
questionnaire and Dutch Norm of Healthy Exercise / Fitstandard, accelerometer);
work status; Quality of life (SF-12 and EQ-5D); patient satisfaction; health
care usage; radiological outcome (post-operative femorotibial angle (knee) and
alignment of the stem and inclination of the cup (Hip) and post-operative
complications.
Determinants of outcome are: sociodemographic characteristics (age, sex);
comorbidities (comorbidity questionnaire, Charnley classification and ASA
classification); frailty (>70 years of age: Groningen Frailty Index);
pre-operative use of pharmacological and non-pharmacological treatment for hip
or knee pain; outcome expectations (the New York Hospital for Special Surgery
Questionnaire);
Background summary
The number of people undergoing total hip or total knee surgery is growing. The
majority of these patients has a favorable outcome with respect to pain,
function and quality of life. In a small group of patients however the results
are disappointing, between 7-34%. Until now, despite the availability of hip
and knee registries and a considerable number of studies on the outcomes in
terms of prosthesis survival, hip and knee function and quality of life, few
studies have focused on the impact of total hip and knee surgery on societal
participation (physical activity, sports, paid and unpaid work) and on health
care usage, including rehabilitation.
The LOAS study, started in Leiden in 2014, is focused on the possible
predictors in outcome after THA or TKA surgery. The reported foot and ankle
complaints are most likely to be related to foot and ankle osteoarthritis as
this condition is relatively common. However, so far little is known on the
presence of clinical and radiological foot and ankle osteoarthritis in patients
undergoing Total Hip or Knee Arthroplasty (THA/TKA).
Study objective
To determine:
* The occurrence of foot and ankle complaints in patients who are undergoing
THA or TKA
* The occurrence of radiographic OA of the forefoot, midfoot and ankle in
patients who are undergoing THA or TKA
* The association between foot and ankle complaints and the severity of
radiographic OA of the forefoot, midfoot and ankle and presurgery and
postsurgery outcomes.
Study design
This study is an addition to the Longitudinal Leiden Orthopeadics and Outcomes
of Osteoarthritis Study (LOAS), a larger prospective, multicenter cohort study
including patients undergoing primary THA or TKA. The current project will have
a prospective design and will only run in the Alrijne Hospital for a limited
time period of 12 months starting in Februari 2016. All patients scheduled for
THA or TKA and are taking part in the LOAS study (minimum of 178 THA patients
and 178 TKA patients with hip or knee osteoarthritis, our aim is 200 patients
in each group) are eligible for the present study. This sample size is
determined on 178 in each group (THA and TKA) based on a power of 0.80 and an
effect size of 0.3 (medium).
Study burden and risks
This study is observational in nature, is embedded in standard treatment
(primary total hip or total knee surgery in patients with hip or knee
osteoarthritis) and consists of questionnaires (FFI and FAOS with supplement
questions) which patients can answer when at the pre-operative contact.
The extent of the burden and risk of the patients is nil.
The additional five X-rays of the foot and ankle (Mortise view, AP and Lateral
view) will add an effective dose of 3,47E-04milliSv of radiation.
The highest mortalityrisk due to radiationbased tumours is 8.27 E -07%. So the
increase of effective dose is nil.
Simon Smitweg 1
Leiderdorp 2353 GA
NL
Simon Smitweg 1
Leiderdorp 2353 GA
NL
Listed location countries
Age
Inclusion criteria
All patients scheduled for THA or TKA and are taking part in the LOAS study (minimum of 178 THA patients and 178 TKA patients with hip or knee osteoarthritis, our aim is 200 patients in each group) are eligible for the present study.
Exclusion criteria
< 18 year of age
not capable of answerring the questionnaires
not capable of understanding Dutch language
Design
Recruitment
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 | NL56450.058.16 |