Arthroplasty, Replacement, KneeNCT03008967
A Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark
An observational study of Arthroplasty, Replacement, Knee and Arthroplasty, Replacement, Hip, run by Bornholms Regionskommune at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Hip
- What is being tested?
- Arthroplasty and postoperative rehabilitation.
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2016to Feb 2018
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- patients undergoing total knee arthroplasty or total hip arthroplasty
- must be able to participate in postoperative rehabilitation
- must be able to talk and understand Danish or English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Being tested
- Arthroplasty and postoperative rehabilitation.
- Keywords
- Total Knee Arthroplasty, Total Hip Arthroplasty, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroplasty and postoperative rehabilitation.Other
Patients undergoing total knee or total hip arthroplasty and their response to postoperative rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Total Knee and Hip Arthroplasty | Rehabilitation, observational. Identification of risk factors for poor response to rehabilitation programs after TJR and use these to identify patients who are most susceptible to poor outcomes Receives: Other: Arthroplasty and postoperative rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 second chair stand test, to test the patients functional capacity
Measured: Change of 30 second chair stand test from baseline to follow up (an average of 3 months)
Secondary outcomes (8)
Health-related quality of life questionnaire
Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS)
Measured: Change of health-related quality of life questionnaire from baseline to follow up (an average of 3 months)
Pain catastrophizing scale questionnaire
Measured: Change of pain catastrophizing scale questionnaire from baseline to follow up (an average of 3 months)
Use of analgesics and other medication, qualitative assessment
Measured: Changes in the use og analgesics and other medication from baseline to follow up (an average of 3 months)
Fall history, events as numbers of falls described by the patient
Measured: Change within the fall history from baseline to follow up (an average of 3 months)
Patient expectations questionnaire
Measured: Preoperative (an average 3 weeks before surgery)
Patient satisfaction questionnaire
Measured: At follow up (an average of 3 months postoperative).
The Forgotten Joint Score questionnaire
Measured: At follow up (an average of 3 months postoperative).
Rehabilitation compliance
Physiotherapist subjective assessment of patient compliance to the rehabilitation program
Measured: At the culmination of the rehabilitation program, an average of 10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Bornholms Regionskommune
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Troels Mark Christensen, Bornholms Regionskommune
- Investigators
- Troels M. Christensen, MSc, Principal investigator, Bornholms Regionskommune
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008967
- Sponsor's protocol ID
- 2016-41-4783
- Status last verified
- Jan 2018
- First submitted
- 9 Sep 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Aasvang EK, Luna IE, Kehlet H. Challenges in postdischarge function and recovery: the case of fast-track hip and knee arthroplasty. Br J Anaesth. 2015 Dec;115(6):861-6. doi: 10.1093/bja/aev257. Epub 2015 Jul 25.
PubMed 26209853Artz N, Elvers KT, Lowe CM, Sackley C, Jepson P, Beswick AD. Effectiveness of physiotherapy exercise following total knee replacement: systematic review and meta-analysis. BMC Musculoskelet Disord. 2015 Feb 7;16:15. doi: 10.1186/s12891-015-0469-6.
PubMed 25886975Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.
PubMed 22000572Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
PubMed 19844772Burns LC, Ritvo SE, Ferguson MK, Clarke H, Seltzer Z, Katz J. Pain catastrophizing as a risk factor for chronic pain after total knee arthroplasty: a systematic review. J Pain Res. 2015 Jan 5;8:21-32. doi: 10.2147/JPR.S64730. eCollection 2015.
PubMed 25609995Collins NJ, Prinsen CA, Christensen R, Bartels EM, Terwee CB, Roos EM. Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis Cartilage. 2016 Aug;24(8):1317-29. doi: 10.1016/j.joca.2016.03.010. Epub 2016 Mar 21.
PubMed 27012756Di Monaco M, Castiglioni C. Which type of exercise therapy is effective after hip arthroplasty? A systematic review of randomized controlled trials. Eur J Phys Rehabil Med. 2013 Dec;49(6):893-907, quiz 921-3. Epub 2013 Oct 30.
PubMed 24172644Dobson F, Hinman RS, Hall M, Terwee CB, Roos EM, Bennell KL. Measurement properties of performance-based measures to assess physical function in hip and knee osteoarthritis: a systematic review. Osteoarthritis Cartilage. 2012 Dec;20(12):1548-62. doi: 10.1016/j.joca.2012.08.015. Epub 2012 Aug 31.
PubMed 22944525Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
PubMed 23680877Dowsey MM, Gunn J, Choong PF. Selecting those to refer for joint replacement: who will likely benefit and who will not? Best Pract Res Clin Rheumatol. 2014 Feb;28(1):157-71. doi: 10.1016/j.berh.2014.01.005.
PubMed 24792950Granot M, Ferber SG. The roles of pain catastrophizing and anxiety in the prediction of postoperative pain intensity: a prospective study. Clin J Pain. 2005 Sep-Oct;21(5):439-45. doi: 10.1097/01.ajp.0000135236.12705.2d.
PubMed 16093750Harding PA, Holland AE, Hinman RS, Delany C. Physical activity perceptions and beliefs following total hip and knee arthroplasty: a qualitative study. Physiother Theory Pract. 2015 Feb;31(2):107-13. doi: 10.3109/09593985.2014.959581. Epub 2014 Dec 12.
PubMed 25495877Jorgensen CC, Kehlet H; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Fall-related admissions after fast-track total hip and knee arthroplasty - cause of concern or consequence of success? Clin Interv Aging. 2013;8:1569-77. doi: 10.2147/CIA.S52528. Epub 2013 Nov 26.
PubMed 24348026Kehlet H. Fast-track hip and knee arthroplasty. Lancet. 2013 May 11;381(9878):1600-2. doi: 10.1016/S0140-6736(13)61003-X. No abstract available.
PubMed 23663938Kjogx H, Zachariae R, Pfeiffer-Jensen M, Kasch H, Svensson P, Jensen TS, Vase L. Pain frequency moderates the relationship between pain catastrophizing and pain. Front Psychol. 2014 Dec 19;5:1421. doi: 10.3389/fpsyg.2014.01421. eCollection 2014.
PubMed 25646089
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Patients Undergoing Total Knee and Hip Arthroplasty at a Regional Hospital in Denmark
- ClinicalTrials.gov ID
- NCT03008967
- Acronym / sponsor ID
- 2016-41-4783
- Keywords
- Total Knee Arthroplasty, Total Hip Arthroplasty, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Bornholms RegionskommuneOther government
- Study start
- Sep 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Knee and Hip Arthroplasty | – | Other: Arthroplasty and postoperative rehabilitation.Rehabilitation, observational. Identification of risk factors for poor response to rehabilitation programs after TJR and use these to identify patients who are most susceptible to poor outcomes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- patients undergoing total knee arthroplasty or total hip arthroplasty
- must be able to participate in postoperative rehabilitation
- must be able to talk and understand Danish or English
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroplasty and postoperative rehabilitation.Patients undergoing total knee or total hip arthroplasty and their response to postoperative rehabilitation. | Other | Total Knee and Hip Arthroplasty |
Primary outcome
30 second chair stand test, to test the patients functional capacity
Time frame: Change of 30 second chair stand test from baseline to follow up (an average of 3 months)
8 secondary outcomes
Health-related quality of life questionnaire
Time frame: Change of health-related quality of life questionnaire from baseline to follow up (an average of 3 months)
Pain catastrophizing scale questionnaire
Time frame: Change of pain catastrophizing scale questionnaire from baseline to follow up (an average of 3 months)
Use of analgesics and other medication, qualitative assessment
Time frame: Changes in the use og analgesics and other medication from baseline to follow up (an average of 3 months)
Fall history, events as numbers of falls described by the patient
Time frame: Change within the fall history from baseline to follow up (an average of 3 months)
Patient expectations questionnaire
Time frame: Preoperative (an average 3 weeks before surgery)
Patient satisfaction questionnaire
Time frame: At follow up (an average of 3 months postoperative).
The Forgotten Joint Score questionnaire
Time frame: At follow up (an average of 3 months postoperative).
Rehabilitation compliance
Time frame: At the culmination of the rehabilitation program, an average of 10 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Background: PubMed 26209853Aasvang EK, Luna IE, Kehlet H. Challenges in postdischarge function and recovery: the case of fast-track hip and knee arthroplasty. Br J Anaesth. 2015 Dec;115(6):861-6. doi: 10.1093/bja/aev257. Epub 2015 Jul 25.
- Background: PubMed 25886975Artz N, Elvers KT, Lowe CM, Sackley C, Jepson P, Beswick AD. Effectiveness of physiotherapy exercise following total knee replacement: systematic review and meta-analysis. BMC Musculoskelet Disord. 2015 Feb 7;16:15. doi: 10.1186/s12891-015-0469-6.
- Background: PubMed 22000572Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.
- Background: PubMed 19844772Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
- Background: PubMed 25609995Burns LC, Ritvo SE, Ferguson MK, Clarke H, Seltzer Z, Katz J. Pain catastrophizing as a risk factor for chronic pain after total knee arthroplasty: a systematic review. J Pain Res. 2015 Jan 5;8:21-32. doi: 10.2147/JPR.S64730. eCollection 2015.
- Background: PubMed 27012756Collins NJ, Prinsen CA, Christensen R, Bartels EM, Terwee CB, Roos EM. Knee Injury and Osteoarthritis Outcome Score (KOOS): systematic review and meta-analysis of measurement properties. Osteoarthritis Cartilage. 2016 Aug;24(8):1317-29. doi: 10.1016/j.joca.2016.03.010. Epub 2016 Mar 21.
- Background: PubMed 24172644Di Monaco M, Castiglioni C. Which type of exercise therapy is effective after hip arthroplasty? A systematic review of randomized controlled trials. Eur J Phys Rehabil Med. 2013 Dec;49(6):893-907, quiz 921-3. Epub 2013 Oct 30.
- Background: PubMed 22944525Dobson F, Hinman RS, Hall M, Terwee CB, Roos EM, Bennell KL. Measurement properties of performance-based measures to assess physical function in hip and knee osteoarthritis: a systematic review. Osteoarthritis Cartilage. 2012 Dec;20(12):1548-62. doi: 10.1016/j.joca.2012.08.015. Epub 2012 Aug 31.
- Background: PubMed 23680877Dobson F, Hinman RS, Roos EM, Abbott JH, Stratford P, Davis AM, Buchbinder R, Snyder-Mackler L, Henrotin Y, Thumboo J, Hansen P, Bennell KL. OARSI recommended performance-based tests to assess physical function in people diagnosed with hip or knee osteoarthritis. Osteoarthritis Cartilage. 2013 Aug;21(8):1042-52. doi: 10.1016/j.joca.2013.05.002. Epub 2013 May 13.
- Background: PubMed 24792950Dowsey MM, Gunn J, Choong PF. Selecting those to refer for joint replacement: who will likely benefit and who will not? Best Pract Res Clin Rheumatol. 2014 Feb;28(1):157-71. doi: 10.1016/j.berh.2014.01.005.
- Background: PubMed 16093750Granot M, Ferber SG. The roles of pain catastrophizing and anxiety in the prediction of postoperative pain intensity: a prospective study. Clin J Pain. 2005 Sep-Oct;21(5):439-45. doi: 10.1097/01.ajp.0000135236.12705.2d.
- Background: PubMed 25495877Harding PA, Holland AE, Hinman RS, Delany C. Physical activity perceptions and beliefs following total hip and knee arthroplasty: a qualitative study. Physiother Theory Pract. 2015 Feb;31(2):107-13. doi: 10.3109/09593985.2014.959581. Epub 2014 Dec 12.
- Individual participant dataSharing planned: Yes
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Tau Pathology in the Brain After Hip or Knee Replacement Surgery
Postoperative Cognitive Dysfunction, Alzheimer Disease
RecruitingPhase 3
Suzetrigine in TKA
Total Knee Arthroplasty (TKA), Total Knee Arthroplasty \(TKA\)
Not yet recruiting
The Effect of White and Pink Noise in Patients Undergoing Total Hip and Knee Arthroplasty
Arthroplasty, Replacement, Knee, Hip, Postoperative Nausea and Vomiting
Recruiting
Binaural Beats for Postoperative Pain and Anxiety Reduction
TKA, THA
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troels M. Christensen, MSc principal investigator
Bornholms Regionskommune
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Knee and Arthroplasty, Replacement, Hip, run by Bornholms Regionskommune at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 second chair stand test, to test the patients functional capacity (time frame: Change of 30 second chair stand test from baseline to follow up (an average of 3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03008967, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018; AzTrials last refreshed its copy on 26 Oct 2026.