Given the above mentioned gaps in knowledge, the aim of this project is to1) Describe the midterm and long-term outcomes of (primary and revision) total hip, total knee and shoulder replacement surgery in terms of health status as a whole, including…
ID
Source
Brief title
Condition
- Joint disorders
- Therapeutic procedures and supportive care NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessments will be done at baseline (pre-operatively), 3, 6, 12, and 24 months
postoperatively and every 2 years thereafter until 10 years post-surgery.
Main outcome parameters are: NRS pain at rest and during physical activity,
knee, hip or shoulder functioning (HOOS-PS/KOOS-PS and Oxford Hip/Knee/Shoulder
Score); Sleep quality (Pitsburg Sleep Quality Index (PSQI)), PROMIS physical
(Mobility/Upper Extremity) and Cognitive Function; physical activity (Dutch
Norm of Healthy Exercise / Fitstandard); work status; Quality of life (SF-12
and EQ-5D); patient satisfaction; health care usage; radiological outcome
(post-operative femorotibial angle (knee); alignment of the stem, inclination
of the cup (Hip); alignment and orientation of the humeral stem and glenoid.,
three anchor questions on outcome (Likert scale 0-4) and post-operative
complications (including progression of osteoarthritis in other joints and
venous thromboembolism).
Main potential 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,
knee or shoulder pain; outcome expectations (Credibility / Expectancy
Questionnaire); preoperative radiographic osteoarthritisdamage (Kellgren score
(hip, knee and shoulder), femorotibial angle and alignment of the stem and
inclination of the cup (hip) and for the shoulder the Walch score,
acromio-humeral distance and rotator cuff status will be measured. patient and
surgery characteristics which could predict postoperative complications, (risk
factor questionnaires).
Secondary outcome
not applicable
Background summary
The number of people undergoing total hip, total knee or shoulder replacement
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. Until now, despite the availability of
hip, knee and shoulder registries and a considerable number of studies on the
outcomes in terms of prosthesis survival, joint function and quality of life,
few studies have focused on the impact of total hip, knee and shoulder surgery
on societal participation (physical activity, sports, paid and unpaid work) and
on health care usage, including rehabilitation. Information to patients on more
general less favourable outcomes, ranging from complications to the sequelae
after joint replacement surgery is often lacking. For that matter, an analysis
of including patient reported outcome before and after revision surgery,
progression of osteoarthritis in other joints (after the replaced joint) as
well as presence of more general complications like and venous thromboembolism
are important before a patient can make well balanced decision with his
orthopaedic surgeon to have a joint arthroplasty. These collected data will
give input to preventive measures reducing less favourable outcome to patients,
is lacking as well. Moreover, concerning the predictors of outcome, currently
available studies did not comprehensively include the role of personal factors
such as treatment expectancies nor preoperative pain sensitisation on outcome.
Study objective
Given the above mentioned gaps in knowledge, the aim of this project is to
1) Describe the midterm and long-term outcomes of (primary and revision) total
hip, total knee and shoulder replacement surgery in terms of health status as a
whole, including the levels of body functions and structures, daily activities,
participation in society, health care usage, and complications of joint
replacement surgery, such as venous thrombosis as well as progression of the
*disease* osteoarthritis in other joints.
2) Determine which factors predict the outcomes of elective primary and
revision total hip, total knee and shoulder replacement surgery, as mentioned
under aim 1.
The results of this analysis will contribute to a better selection of patients
who will profit most from elective primary and revision total hip, total knee
and shoulder replacement surgery and to tailored rehabilitation treatment
strategies, as well as prevention of complications after joint replacement
surgery.
The aims will be achieved by setting up a structure for building a large,
standardized database regarding the outcomes of hip, knee and shoulder
replacement surgery, called LOAS (Longitudinal Leiden Orthopaedics Outcomes of
Osteoarthritis Study). The structure of this database will be aimed to be like
*The String of Pearls Initiative* (*Het Parelsnoer Initiatief*,
www.parelsnoer.org).
Study design
This project has a multicenter, longitudinal (prospective) design, and includes
all consecutive patients undergoing hip or knee surgery in 9 general hospitals
and one university hospital in the region Zuid-Holland, Noord-Holland and
Overijssel in The Netherlands. The duration of the study is 23 years in total,
with the inclusion period being 13 years and the duration of follow-up 10
years. For longer-term follow-up additional ethical consent will be requested.
Study burden and risks
This study is observational in nature, is embedded in standard treatment
(primary total hip, total knee or shoulder arthroplasty surgery in patients
with hip, knee and shoulder osteoarthritis) and mainly consists of
questionnaires.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
• Patients, who are scheduled for primary total hip, total knee or shoulder
arthroplasty surgery or revision surgery
• Are able to complete questionnaires, either on paper or electronically
•Patients > 18 years of age
Exclusion criteria
• No informed consent signed or electronic informed consent provided
• Insufficient Dutch language skills
• Physical or mental status not allowing participation
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL39663.058.12 |
Other | TC=3348 |