Post Operative PainKATUKANCT05510947
Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty
An observational study of Post Operative Pain, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
Advantages of unicompartmental knee arthroplasty (UKA) compared to total knee arthroplasty (TKA) include shorter hospital stays, faster recovery, fewer infections and readmission, and lower costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- How many people
- 146 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2022to 4 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients planned for unicompartmental knee arthroplasty at a Danish hospital.
Who may be able to join
- Primary unilateral UKA
- Age ≥ 18 years
- Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
- Filled out the Pain Catastrophizing Scale preoperatively.
- Signed written informed consent form.
Who cannot join
- Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
- Insulin-treated diabetes mellitus
- Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
- Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.
- Peripheral nerve block per- or postoperatively.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty - A Prospective, Observational, Single-center, Cohort Study
Advantages of unicompartmental knee arthroplasty (UKA) compared to total knee arthroplasty (TKA) include shorter hospital stays, faster recovery, fewer infections and readmission, and lower costs. It is well documented in TKA-surgery that high pain responders (HPR), evaluated using the Pain Catastrophizing Scale (PCS), have higher postoperative pain responses compared to low pain responders (LPR). These HPR-patients constitute a vulnerable high risk patient group and potentially benefit from targeted treatment. Currently, the distribution of HPR- and LPR-patients and their association with acute pain following UKA is not well investigated. The knowledge that this research project generates is essential to determine how studies with analgesia interventions should be designed. In the future this will contribute in targeting treatment for high risk patient groups to reduce pain and improve postoperative mobilization, and ultimately decrease length of hospital stay in patients undergoing UKA. By targeting treatment, a potential overtreatment is also avoided.
The aim of this study is to investigate the prevalence of high- and low-pain responders, defined by a PCS score > 20 and ≤ 20 respectively, as well as the acute postoperative course of pain for these groups after unicompartmental knee arthroplasty.
Read the detailed description
Background:
Primary knee arthroplasty is a frequently performed procedure and is expected to increase in numbers over the next decade. Advantages of unicompartmental knee arthroplasty (UKA) compared to total knee arthroplasty (TKA) include shorter hospital stays, faster recovery, fewer infections and readmissions, and lower costs. The length of hospital stay after UKA is variable, but an increased length of hospitalization has been associated with more complications and higher readmission rates. A recent study has shown that the main reasons for continued hospitalization beyond 24 hours after surgery are pain and lack of mobilization. Strategies to decrease the length of stay after UKA should thus be aimed at improved analgesia and postoperative mobilization.
There is a large interindividual variability in the postoperative pain response. It is well documented in TKA-surgery that high pain responders (HPR), evaluated using the Pain Catastrophizing Scale (PCS), have higher postoperative pain responses compared to low pain responders (LPR). Recently, it has been shown that HPR patients undergoing TKA benefit from a larger preoperative dose of glucocorticoid compared to a previously recommended dose. Interestingly, the same difference has not been found in LPR patients (Nielsen et al.: IN PREPARATION, clinicaltrials.gov ID NCT03758170, EudraCT 2018-002634-20, VEK H-18034756). These HPR patients constitute a vulnerable high-risk patient group and potentially benefit from targeted treatment.
Currently, the distribution of HPR- and LPR patients and their association with acute pain following UKA is not well investigated. The generated knowledge from this research project is essential to determine how studies with analgesia interventions should be designed. In the future, this will contribute to targeting treatment for high-risk patient groups to reduce pain and improve postoperative mobilization, and ultimately decrease the length of hospital stay in patients undergoing UKA. By targeting treatment, a potential overtreatment is also avoided.
Aim:
To investigate the prevalence of high- and low-pain responders, defined by a PCS score > 20 and ≤ 20 respectively, as well as the acute postoperative course of pain for these groups after unicompartmental knee arthroplasty.
Study location:
The inclusion will take place at the Dept. of Orthopaedic Surgery, Arthroplasty unit at Hvidovre Hospital, Capital Region of Denmark.
Study plan:
In the outpatient clinic, the screening procedure will be performed among patients planned to UKA by the surgeons. Patients will be asked if they may be contacted with the purpose of participating in a research project. Patients will undergo a preliminary examination where, as a standard procedure, the patient will receive a PCS questionnaire. Patients will be informed of the research project either in the outpatient clinic or by phone from an investigator.
All patients will receive verbal and written information about the project. All patients must give a signed informed consent on paper prior to inclusion to participate in the study.
Data protection:
All patient-related information will be treated confidentially, and data will be pseudoanonymized. Signed informed consent from participating patients will be stored at the Anesthesiologic Dept. 542, Hvidovre Hospital, in a locked cabinet. All electronic data will be stored in REDCap.
Collected variables:
During the hospital stay, data will be collected by contacting the patient at the Orthopaedic Dept. and by accessing the electronic patient journal. After discharge patients will be asked to fill out an electronic pain diary until 7 days after the operation.
- Conditions
- Post Operative Pain
- Keywords
- Acute Postoperative Pain, Unicompartmental Knee Arthroplasty, Pain catastrophizing scale
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio between HPR:LPR patients defined as patients with PCS > 20 and PCS ≤ 20 respectively
Measured: Preoperatively
Secondary outcomes (2)
Incidence of moderate to severe pain (VAS > 30 mm) during a 5-meter walk test 24 hours postoperatively in LPR patients
Measured: 24 hours
Incidence of moderate to severe pain (VAS > 30 mm) during a 5-meter walk test 24 hours postoperatively in HPR patients
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Sep 2022
- Primary completion27 Sep 2023
- Study completion4 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Anders Deichmann Springborg, Copenhagen University Hospital, Hvidovre
- Investigators
- Nicolai B Foss, MD, dr.med., Study director, Department of Anaesthesiology, Copenhagen University Hospital Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510947
- Sponsor's protocol ID
- UKAPCS
- Acronym
- KATUKA
- Status last verified
- Feb 2024
- First submitted
- 17 Aug 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual patient data will be made available in anonymized form.
Publications
Beard DJ, Davies LJ, Cook JA, MacLennan G, Price A, Kent S, Hudson J, Carr A, Leal J, Campbell H, Fitzpatrick R, Arden N, Murray D, Campbell MK; TOPKAT Study Group. The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial. Lancet. 2019 Aug 31;394(10200):746-756. doi: 10.1016/S0140-6736(19)31281-4. Epub 2019 Jul 17.
PubMed 31326135Birch S, Stilling M, Mechlenburg I, Hansen TB. The association between pain catastrophizing, physical function and pain in a cohort of patients undergoing knee arthroplasty. BMC Musculoskelet Disord. 2019 Sep 12;20(1):421. doi: 10.1186/s12891-019-2787-6.
PubMed 31511076Hansen EN, Ong KL, Lau E, Kurtz SM, Lonner JH. Unicondylar Knee Arthroplasty Has Fewer Complications but Higher Revision Rates Than Total Knee Arthroplasty in a Study of Large United States Databases. J Arthroplasty. 2019 Aug;34(8):1617-1625. doi: 10.1016/j.arth.2019.04.004. Epub 2019 Apr 8.
PubMed 31064725Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.
PubMed 28801208Jensen CB, Petersen PB, Jorgensen CC, Kehlet H, Troelsen A, Gromov K; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Length of Stay and 90-Day Readmission/Complication Rates in Unicompartmental Versus Total Knee Arthroplasty: A Propensity-Score-Matched Study of 10,494 Procedures Performed in a Fast-Track Setup. J Bone Joint Surg Am. 2021 Jun 16;103(12):1063-1071. doi: 10.2106/JBJS.20.01287.
PubMed 33784260Jensen CB, Troelsen A, Nielsen CS, Otte NKS, Husted H, Gromov K. Why are patients still in hospital after fast-track, unilateral unicompartmental knee arthroplasty. Acta Orthop. 2020 Aug;91(4):433-438. doi: 10.1080/17453674.2020.1751952. Epub 2020 Apr 14.
PubMed 32285727Kim MS, Koh IJ, Choi YJ, Lee JY, In Y. Differences in Patient-Reported Outcomes Between Unicompartmental and Total Knee Arthroplasties: A Propensity Score-Matched Analysis. J Arthroplasty. 2017 May;32(5):1453-1459. doi: 10.1016/j.arth.2016.11.034. Epub 2016 Nov 27.
PubMed 27979407Liddle AD, Pandit H, Judge A, Murray DW. Patient-reported outcomes after total and unicompartmental knee arthroplasty: a study of 14,076 matched patients from the National Joint Registry for England and Wales. Bone Joint J. 2015 Jun;97-B(6):793-801. doi: 10.1302/0301-620X.97B6.35155.
PubMed 26033059Lunn TH, Frokjaer VG, Hansen TB, Kristensen PW, Lind T, Kehlet H. Analgesic effect of perioperative escitalopram in high pain catastrophizing patients after total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2015 Apr;122(4):884-94. doi: 10.1097/ALN.0000000000000597.
PubMed 25782644Lunn TH, Gaarn-Larsen L, Kehlet H. Prediction of postoperative pain by preoperative pain response to heat stimulation in total knee arthroplasty. Pain. 2013 Sep;154(9):1878-1885. doi: 10.1016/j.pain.2013.06.008. Epub 2013 Jun 12.
PubMed 23769717Nemes S, Rolfson O, W-Dahl A, Garellick G, Sundberg M, Karrholm J, Robertsson O. Historical view and future demand for knee arthroplasty in Sweden. Acta Orthop. 2015;86(4):426-31. doi: 10.3109/17453674.2015.1034608. Epub 2015 Mar 25.
PubMed 25806653Ode Q, Gaillard R, Batailler C, Herry Y, Neyret P, Servien E, Lustig S. Fewer complications after UKA than TKA in patients over 85 years of age: A case-control study. Orthop Traumatol Surg Res. 2018 Nov;104(7):955-959. doi: 10.1016/j.otsr.2018.02.015. Epub 2018 Apr 21.
PubMed 29684539Otero JE, Gholson JJ, Pugely AJ, Gao Y, Bedard NA, Callaghan JJ. Length of Hospitalization After Joint Arthroplasty: Does Early Discharge Affect Complications and Readmission Rates? J Arthroplasty. 2016 Dec;31(12):2714-2725. doi: 10.1016/j.arth.2016.07.026. Epub 2016 Aug 9.
PubMed 27600301Pavlin DJ, Sullivan MJ, Freund PR, Roesen K. Catastrophizing: a risk factor for postsurgical pain. Clin J Pain. 2005 Jan-Feb;21(1):83-90. doi: 10.1097/00002508-200501000-00010.
PubMed 15599135Pinto PR, McIntyre T, Ferrero R, Almeida A, Araujo-Soares V. Predictors of acute postsurgical pain and anxiety following primary total hip and knee arthroplasty. J Pain. 2013 May;14(5):502-15. doi: 10.1016/j.jpain.2012.12.020. Epub 2013 Mar 27.
PubMed 23541065
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty - A Prospective, Observational, Single-center, Cohort Study
- ClinicalTrials.gov ID
- NCT05510947
- Acronym / sponsor ID
- KATUKA / UKAPCS
- Conditions
- Post Operative Pain
- Keywords
- Acute Postoperative Pain, Unicompartmental Knee Arthroplasty, Pain catastrophizing scale
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 4 Oct 2023 (actual)
- First posted
- 22 Aug 2022 (actual)
- 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.
Advantages of unicompartmental knee arthroplasty (UKA) compared to total knee arthroplasty (TKA) include shorter hospital stays, faster recovery, fewer infections and readmission, and lower costs. It is well documented in TKA-surgery that high pain responders (HPR), evaluated using the Pain Catastrophizing Scale (PCS), have higher postoperative pain responses compared to low pain responders (LPR). These HPR-patients constitute a vulnerable high risk patient group and potentially benefit from targeted treatment. Currently, the distribution of HPR- and LPR-patients and their association with acute pain following UKA is not well investigated. The knowledge that this research project generates is essential to determine how studies with analgesia interventions should be designed. In the future this will contribute in targeting treatment for high risk patient groups to reduce pain and improve postoperative mobilization, and ultimately decrease length of hospital stay in patients undergoing UKA. By targeting treatment, a potential overtreatment is also avoided.
The aim of this study is to investigate the prevalence of high- and low-pain responders, defined by a PCS score > 20 and ≤ 20 respectively, as well as the acute postoperative course of pain for these groups after unicompartmental knee arthroplasty.
Detailed description
Background:
Primary knee arthroplasty is a frequently performed procedure and is expected to increase in numbers over the next decade. Advantages of unicompartmental knee arthroplasty (UKA) compared to total knee arthroplasty (TKA) include shorter hospital stays, faster recovery, fewer infections and readmissions, and lower costs. The length of hospital stay after UKA is variable, but an increased length of hospitalization has been associated with more complications and higher readmission rates. A recent study has shown that the main reasons for continued hospitalization beyond 24 hours after surgery are pain and lack of mobilization. Strategies to decrease the length of stay after UKA should thus be aimed at improved analgesia and postoperative mobilization.
There is a large interindividual variability in the postoperative pain response. It is well documented in TKA-surgery that high pain responders (HPR), evaluated using the Pain Catastrophizing Scale (PCS), have higher postoperative pain responses compared to low pain responders (LPR). Recently, it has been shown that HPR patients undergoing TKA benefit from a larger preoperative dose of glucocorticoid compared to a previously recommended dose. Interestingly, the same difference has not been found in LPR patients (Nielsen et al.: IN PREPARATION, clinicaltrials.gov ID NCT03758170, EudraCT 2018-002634-20, VEK H-18034756). These HPR patients constitute a vulnerable high-risk patient group and potentially benefit from targeted treatment.
Currently, the distribution of HPR- and LPR patients and their association with acute pain following UKA is not well investigated. The generated knowledge from this research project is essential to determine how studies with analgesia interventions should be designed. In the future, this will contribute to targeting treatment for high-risk patient groups to reduce pain and improve postoperative mobilization, and ultimately decrease the length of hospital stay in patients undergoing UKA. By targeting treatment, a potential overtreatment is also avoided.
Aim:
To investigate the prevalence of high- and low-pain responders, defined by a PCS score > 20 and ≤ 20 respectively, as well as the acute postoperative course of pain for these groups after unicompartmental knee arthroplasty.
Study location:
The inclusion will take place at the Dept. of Orthopaedic Surgery, Arthroplasty unit at Hvidovre Hospital, Capital Region of Denmark.
Study plan:
In the outpatient clinic, the screening procedure will be performed among patients planned to UKA by the surgeons. Patients will be asked if they may be contacted with the purpose of participating in a research project. Patients will undergo a preliminary examination where, as a standard procedure, the patient will receive a PCS questionnaire. Patients will be informed of the research project either in the outpatient clinic or by phone from an investigator.
All patients will receive verbal and written information about the project. All patients must give a signed informed consent on paper prior to inclusion to participate in the study.
Data protection:
All patient-related information will be treated confidentially, and data will be pseudoanonymized. Signed informed consent from participating patients will be stored at the Anesthesiologic Dept. 542, Hvidovre Hospital, in a locked cabinet. All electronic data will be stored in REDCap.
Collected variables:
During the hospital stay, data will be collected by contacting the patient at the Orthopaedic Dept. and by accessing the electronic patient journal. After discharge patients will be asked to fill out an electronic pain diary until 7 days after the operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients planned for unicompartmental knee arthroplasty at a Danish hospital.
Key inclusion criteria (5 listed)
- Primary unilateral UKA
- Age ≥ 18 years
- Ability to participate in the study (understand written and spoken Danish language, self-reported pain and satisfaction).
- Filled out the Pain Catastrophizing Scale preoperatively.
- Signed written informed consent form.
Key exclusion criteria (5 listed)
- Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
- Insulin-treated diabetes mellitus
- Patients with known diagnoses of schizophrenia, ongoing psychosis, bipolar disease and/or a history of ongoing anti-psychotic treatment.
- Patients with modulated pain-reception (experience) based on other diseases or injuries, e.g. spinal cord or brain injury, severe polyneuropathies or neurologic disorders.
- Peripheral nerve block per- or postoperatively.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ratio between HPR:LPR patients defined as patients with PCS > 20 and PCS ≤ 20 respectively
Time frame: Preoperatively
2 secondary outcomes
Incidence of moderate to severe pain (VAS > 30 mm) during a 5-meter walk test 24 hours postoperatively in LPR patients
Time frame: 24 hours
Incidence of moderate to severe pain (VAS > 30 mm) during a 5-meter walk test 24 hours postoperatively in HPR patients
Time frame: 24 hours
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 7 Feb 2024.
- Background: PubMed 31326135Beard DJ, Davies LJ, Cook JA, MacLennan G, Price A, Kent S, Hudson J, Carr A, Leal J, Campbell H, Fitzpatrick R, Arden N, Murray D, Campbell MK; TOPKAT Study Group. The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial. Lancet. 2019 Aug 31;394(10200):746-756. doi: 10.1016/S0140-6736(19)31281-4. Epub 2019 Jul 17.
- Background: PubMed 31511076Birch S, Stilling M, Mechlenburg I, Hansen TB. The association between pain catastrophizing, physical function and pain in a cohort of patients undergoing knee arthroplasty. BMC Musculoskelet Disord. 2019 Sep 12;20(1):421. doi: 10.1186/s12891-019-2787-6.
- Background: PubMed 31064725Hansen EN, Ong KL, Lau E, Kurtz SM, Lonner JH. Unicondylar Knee Arthroplasty Has Fewer Complications but Higher Revision Rates Than Total Knee Arthroplasty in a Study of Large United States Databases. J Arthroplasty. 2019 Aug;34(8):1617-1625. doi: 10.1016/j.arth.2019.04.004. Epub 2019 Apr 8.
- Background: PubMed 28801208Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.
- Background: PubMed 33784260Jensen CB, Petersen PB, Jorgensen CC, Kehlet H, Troelsen A, Gromov K; Lundbeck Foundation Centre for Fast-track Hip and Knee Replacement Collaborative Group. Length of Stay and 90-Day Readmission/Complication Rates in Unicompartmental Versus Total Knee Arthroplasty: A Propensity-Score-Matched Study of 10,494 Procedures Performed in a Fast-Track Setup. J Bone Joint Surg Am. 2021 Jun 16;103(12):1063-1071. doi: 10.2106/JBJS.20.01287.
- Background: PubMed 32285727Jensen CB, Troelsen A, Nielsen CS, Otte NKS, Husted H, Gromov K. Why are patients still in hospital after fast-track, unilateral unicompartmental knee arthroplasty. Acta Orthop. 2020 Aug;91(4):433-438. doi: 10.1080/17453674.2020.1751952. Epub 2020 Apr 14.
- Background: PubMed 27979407Kim MS, Koh IJ, Choi YJ, Lee JY, In Y. Differences in Patient-Reported Outcomes Between Unicompartmental and Total Knee Arthroplasties: A Propensity Score-Matched Analysis. J Arthroplasty. 2017 May;32(5):1453-1459. doi: 10.1016/j.arth.2016.11.034. Epub 2016 Nov 27.
- Background: PubMed 26033059Liddle AD, Pandit H, Judge A, Murray DW. Patient-reported outcomes after total and unicompartmental knee arthroplasty: a study of 14,076 matched patients from the National Joint Registry for England and Wales. Bone Joint J. 2015 Jun;97-B(6):793-801. doi: 10.1302/0301-620X.97B6.35155.
- Background: PubMed 25782644Lunn TH, Frokjaer VG, Hansen TB, Kristensen PW, Lind T, Kehlet H. Analgesic effect of perioperative escitalopram in high pain catastrophizing patients after total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Anesthesiology. 2015 Apr;122(4):884-94. doi: 10.1097/ALN.0000000000000597.
- Background: PubMed 23769717Lunn TH, Gaarn-Larsen L, Kehlet H. Prediction of postoperative pain by preoperative pain response to heat stimulation in total knee arthroplasty. Pain. 2013 Sep;154(9):1878-1885. doi: 10.1016/j.pain.2013.06.008. Epub 2013 Jun 12.
- Background: PubMed 25806653Nemes S, Rolfson O, W-Dahl A, Garellick G, Sundberg M, Karrholm J, Robertsson O. Historical view and future demand for knee arthroplasty in Sweden. Acta Orthop. 2015;86(4):426-31. doi: 10.3109/17453674.2015.1034608. Epub 2015 Mar 25.
- Background: PubMed 29684539Ode Q, Gaillard R, Batailler C, Herry Y, Neyret P, Servien E, Lustig S. Fewer complications after UKA than TKA in patients over 85 years of age: A case-control study. Orthop Traumatol Surg Res. 2018 Nov;104(7):955-959. doi: 10.1016/j.otsr.2018.02.015. Epub 2018 Apr 21.
- Individual participant dataSharing planned: Yes. The individual patient data will be made available in anonymized form.
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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.
Nicolai B Foss, MD, dr.med. study director
Department of Anaesthesiology, Copenhagen University Hospital Hvidovre
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 Post Operative Pain, run by Copenhagen University Hospital, Hvidovre 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 5 inclusion and 5 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 7 Feb 2024. 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?
Ratio between HPR:LPR patients defined as patients with PCS > 20 and PCS ≤ 20 respectively (time frame: Preoperatively). 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 NCT05510947, which also lists 17 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 7 Feb 2024.