Arthroplasty, Replacement, Knee Clinical Trial
Official title:
A Prospective Cohort Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark
This project will be a descriptive, hypothesis-generating study. The aim is to identify risk factors for poor response to rehabilitation programs after TJR and use these to identify patients who are most susceptible to poor outcomes in order to optimise appropriate rehabilitations strategies and rationalising the distribution of health care resources.
Fast-track surgery for total knee and hip arthroplasty has improved markedly in recent years
with decreased hospitalization and postoperative complications. In 2014 there were performed
over 9000 total hip arthroplasty (THA) and over 8500 total knee arthroplasty operations (TKA)
in Denmark. During the same year Bornholm's regional hospital performed 85 THA's and 47 TKA's
of these operations.
Even though the initial surgical procedure being technical and radiological satisfactory,
there are a big proportion of patients who endure dissatisfaction and disability after total
joint replacement (TJR) (between 20-40%). The strongest predictor for dissatisfaction after a
TKA were found to be preoperative expectation not met postoperatively (10.7x greater risk).
To date, there is no criterion standard for assessing the outcome of neither expectations nor
satisfaction for patients undergoing TJR.
Patient's expectations are of a particular significance because they are linked to requests
for elective and often costly treatments. Several studies have investigated the fulfillment
of patient' expectations, however the focus has been primarily assessed by expectations
regarding pain, but may also be influenced by several other factors. Patient's expectations
are also strongly related to patient's assessments of outcome.
It is well established that there is a correlation between satisfaction of surgery and
objective improvements in pain, function and general health-related quality of life, but just
as patient' expectations the postoperative satisfaction may also incorporate multiple and
varies factors that affect the overall outcome. One of these factors can be "ability to
forget the artificial joint" in everyday life and can therefore be regarded as the ultimate
possible goal for patient satisfaction.
Additionally, many patients undergoing TJR experience continued disability, which is largely
caused by persistent pain postoperatively. Studies have shown that a high level of pain
catastrophizing is a predictor of high levels of acute and persistent pain after various
surgeries, and further investigation of pain catastrophizing as a predictor of outcome after
TJR is warranted.
Many of the patients who experience dissatisfaction and disability after TJR do not undergo
revision and present a burden for the community health clinicians and health services to
continue to remedy their dissatisfaction. The rehabilitation after the initial surgery has
been proven to produce short-term benefits, but these benefits does not seem to persist. As
many patients' experiences limited clinical improvements postoperatively and no national
consensus on the rehabilitation for this group, an optimal rehabilitation protocol for this
group of patients is still warranted.
Several other associations between patient characteristics and the chance to achieve
clinically importance improvements to TJR surgery have been identified as age, gender, body
mass index, ethnicity, psychological distress, co-morbidity-profile and radiographic
osteoarthritis severity. It can be speculated that while fast-track surgery aid to early
recovery, the number of falls within the population of patients undergoing total lower limb
arthroplasty will increase as a result from increased, early activities. Jørgensen & Kehlet
found the overall incidence of falls postoperatively in hip and knee replacements to be low,
the inclusion of fall history may be important to optimize the rehabilitation protocol and
reduce future risk of falls in this group of patients.
Patients undergoing lower TJR wish to return to pre-pathological physical status, but there
has been found a limited interest in actually undertaking greater efforts in physical therapy
to fully achieve this either for pleasure or health gains. Individual beliefs and perceptions
presents a big factor influencing physical activity postoperatively and it is therefore
important to examine this further when developing management plans aimed to optimize
rehabilitation in this group of patients.
There is a dearth of literature examining the impact on actual response rates in
rehabilitation after TJR surgery taken fall history, patient expectations, subjective as well
as objective measurements into account. It is therefore important to clarify the relationship
between these characteristics and responsiveness to postoperative rehabilitation. The
available data suggest that identifying and addressing the mechanism for reduced activity and
identification of the group of patients who may or may not benefit from a rehabilitation
programme may be the approach needed. This data can be used to allocate already sparse
resources more beneficially, and to optimise criteria for the rehabilitation intervention. An
expert consensus on the best practice has already identified the need for preoperative
screening to identify patients most in need for rehabilitation for patients undergoing total
hip arthroplasty.
Aim:
This project will be a descriptive, hypothesis-generating study. The aim is to identify risk
factors for poor response to rehabilitation programs after TJR and use these to identify
patients who are most susceptible to poor outcomes in order to optimise appropriate
rehabilitations strategies and rationalising the distribution of health care resources.
Material and methods:
This project will be of a prospective cohort design where all patients who are scheduled to
undergo a total joint replacement (total knee arthroplasty or total hip arthroplasty) at
Bornholms regional hospital will be invited to participate. Due to the minimal effort and
time required filling out the questionnaires and performing the 30sec chair stand test a
minimal number of patients are expected to decline participation. Based on clinical
experience the annual number of patients to undergo lower extremity TJR at Bornholm's
regional hospital is expected to be around 160 patients.
During study enrolment basic, demographic data (e.g. age, gender, co-morbidities, BMI) will
be collected on each participant.
Preoperative assessments (prior to surgery) and postoperative assessments (follow up at 3
months after surgery) will include:
Preoperative assessments:
- Use of joint specific analgesics and other medication
- Fall history
- Patient expectation questionnaire
- Pain catastrophizing questionnaire
- KOOS / HOOS questionnaire
- 30 second chair stand test
Postoperative assessments:
- Use of joint specific analgesics and other medication
- Fall history
- KOOS / HOOS questionnaire
- Pain catastrophizing questionnaire
- 30 second chair stand test
- The Forgotten Joint Score
- Patient satisfaction questionnaire
Approvals:
This cohort study has to obtain approval from the Danish Datatilsynet (J.nr. 2016-41-4783).
This study will not change the pre or postoperative treatment of the included patients, and
therefore no other formal approval is required.
Postoperative rehabilitation:
All patients are given a rehabilitation plan from the hospital to engage in a 4-12 weeks
rehabilitation program in one of two rehabilitations centres located on Bornholm. The
rehabilitation starts with a individual consultation with an experienced physiotherapist
within 3 weeks of surgery where appropriate home-exercises are revised and instructed, and
shortly after the consultation the patient is enrolled in a out-patient, group-based physical
therapy program, twice weekly sessions for 4-12 weeks, where the length of the program
depends on the patients objective response to the physical therapy. The patients are
encouraged to continue their home-based exercises parallel to the physical therapy sessions
and after the culmination of the physical therapy program. At the end of the supervised
physical therapy program, the involved physiotherapist will subjectively assess each
patient's compliance in regards to their exercise adherence to the rehabilitation the
patients have undertaken.
Evaluation of the surgery and rehabilitation intervention is performed at the hospital 3
months after the surgery by the assigned orthopaedic surgeon, where the postoperatively
outcome measurements will be recorded.
Statistical analysis:
The statistical analysis will compare preoperative and postoperative scores in terms of the
use of analgesics, fall history, patient expectations / satisfaction, KOOS / HOOS, pain
catastrophizing, the forgotten joint score and 30sec chair stand test. Significance will be
set to <0.05. A Chi-square test will be used to investigate whether distributions of
categorical variables differ from one another. Multivariable linear regression will be
performed to examine the association between patient characteristics and the response rate to
TKA and THA individually and TKA/THA combined.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
Recruiting |
NCT05002387 -
Diagnostic Knee Needle Arthroscopy in Predicting Unicompartmental Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT06080763 -
Biomechanics and Clinical Outcomes in Responders and Non-Responders
|
||
Withdrawn |
NCT02255877 -
ZIPS Study - Zip Incision Approximation vs. STAPLE
|
Phase 4 | |
Completed |
NCT02642731 -
Kidney Biomarkers of Acute Kidney Injury in Patients With Knee Arthroplasty
|
N/A | |
Completed |
NCT02525588 -
Polyethylene Wear Study on the Triathlon Total Knee Prosthesis
|
N/A | |
Completed |
NCT01799772 -
The Feasibility of a Comprehensive Behavioral Intervention in Patient Post TKA
|
Phase 1/Phase 2 | |
Completed |
NCT02520531 -
Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty
|
N/A | |
Completed |
NCT03183856 -
Comparison of Ambulatory and Functional Improvement by Morning Walk
|
N/A | |
Completed |
NCT03569397 -
Music Therapy Versus Control for Total Knee Arthroplasty
|
N/A | |
Terminated |
NCT02711592 -
Pharmacogenomics Information in Enhancing Post-operative Total Joint Replacement Pain Management: a Pilot Study
|
N/A | |
Completed |
NCT03145493 -
Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid
|
N/A | |
Terminated |
NCT05602701 -
Preoperative Prediction of Postoperative Physical Function
|
||
Recruiting |
NCT03570944 -
Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol (POWER2)
|
||
Withdrawn |
NCT02553122 -
The Combined Efficacy of Evicel and Tranexamic Acid on Total Knee Arthroplasty
|
Phase 3 | |
Completed |
NCT02773537 -
Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial
|
N/A | |
Recruiting |
NCT02385383 -
An Intravenous Iron Based Protocol for Preoperative Anaemia in Hip and Knee Surgery - An Observational Study
|
N/A | |
Completed |
NCT02121392 -
Epidural Catheter With or Without Adductor Canal Nerve Block for Postoperative Analgesia Following Total Knee Arthroplasty
|
N/A | |
Terminated |
NCT02155712 -
Triathlon Tritanium Knee Outcomes Study
|
N/A | |
Completed |
NCT02682498 -
Comparing Post-Op Narcotic Usage in Patients Receiving Periarticular Exparel vs. Standard Periarticular Joint Inj
|
Phase 4 |