Osteo Arthritis KneeNCT05105646
Are Perception of Pain and Psychological Distress Before Knee Arthroplasty Associated With Reason for Revision?
An observational study of Osteo Arthritis Knee and Psychological Distress, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
The aim of our study is to identify the influence of preoperative pain (NRS pain score and EQ5D pain score) and higher levels of anxiety and depression (EQ5D anxiety/depression score) and their interaction before primary total knee arthroplasty on revision surgery for unexplained symptoms after primary surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee, Psychological Distress
- What is being tested?
- Knee Arthroplasty, knee revision arthoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 70,754 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2014to 31 Dec 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing primary knee arthroplasty (e.g., total, unicondylar and patellofemoral) reported in the Dutch Arthroplasty Register.
Who may be able to join
- All patients undergoing primary knee arthroplasty (e.g., total, unicondylar and patellofemoral) reported in the Dutch Arthroplasty Register.
- Patients who filled out the NRS pain score, EQ-5D 3L or EQ-5D 5L pain score or EQ-5D anxiety/depression score.
Who cannot join
- Other types of (revision) arthroplasty (hip / shoulder / ankle)
- Patients who did not fill out the NRS pain score, EQ-5D (3L or 5L) pain score or EQ-5D (3L or 5L) anxiety/depression score
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Preoperative Perception of Pain and Psychological Distress Before Primary Knee Arthroplasty Associated With Reason for Revision Surgery? Results of an Observational Study From the Dutch Arthroplasty Register.
The aim of our study is to identify the influence of preoperative pain (NRS pain score and EQ5D pain score) and higher levels of anxiety and depression (EQ5D anxiety/depression score) and their interaction before primary total knee arthroplasty on revision surgery for unexplained symptoms after primary surgery.
Read the detailed description
Knee arthroplasty can decrease pain and improve function in people with advanced osteoarthritis of the knee. It is a common procedure; over 25,000 primary knee arthroplasties are performed in the Netherlands each year[2]. A primary knee arthroplasty is defined as the first implantation of a prosthesis in the knee. Revision surgery is defined as any exchange (placement, replacement, or removal) or addition of 1 or more components of the prosthesis (e.g. patella resurfacing)[3]. About 12% of knee arthroplasties are revised within 10 years.
It is known that 1 in 5 patients rate themselves categorically dissatisfied after knee arthroplasty (the so-called unhappy knee). It seems sensible that the percentage of patients that has some dissatisfaction with their knee arthroplasty is likely much larger. After knee arthroplasty, some patients receive revision surgery based on clear reasons such as periprosthetic fracture and patellar dislocation, while in some patients that are dissatisfied revision surgery might be considered for less clear reasons such as a small technical issue, for a perceived technical issue, or with the idea that there is a low grade infection. Understanding the preoperative factors of postoperative pain and functional impairment, leading to dissatisfaction, may help to inform patients considering primary knee arthroplasty about the risk of revision surgery. Although pain and function of patients with higher preoperative pain scores before primary knee arthroplasty will improve as much as the scores of patients with lower preoperative pain scores, their final postoperative pain levels and function will remain inferior compared to patients with lower preoperative pain scores. Higher levels of anxiety and symptoms of depression before knee arthroplasty have also been related to worse postoperative patient reported outcome measures after surgery. Furthermore, the experience of pain and symptoms of depression are closely related to each other and they may influence each other in a bidirectional way. Determining the influence of preoperative pain and psychological distress (anxiety/depression) and their interaction on postoperative outcome seems to be crucial because mental and social health opportunities might be underdiagnosed and undertreated and the indication for a revision surgery may be based on a misdiagnosis of perceived or actual pathophysiology or technical deficiency in patients without a clear technical or medical indication for revision.
The aim of this study is to identify the influence of the preoperative pain (NRS pain score and EQ5D pain score) and higher levels of anxiety and depression (EQ5D anxiety/depression score) and their association before primary total knee arthroplasty (TKA) on revision surgery for unexplained symptoms after primary surgery.
- Conditions
- Osteo Arthritis Knee, Psychological Distress
- Being tested
- Knee Arthroplasty, knee revision arthoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee Arthroplasty, knee revision arthoplastyProcedure or surgery
Primary knee arthroplasty (e.g., total, unicondylar and patellofemoral)
| Study group | Role | What they receive |
|---|---|---|
| Patients | • All patients undergoing primary total knee arthroplasty for osteoarthritis of the knee reported in the Dutch Arthroplasty Register.
and
• Patients who filled out the EQ-5D-3L anxiety/depression score. Receives: Procedure: Knee Arthroplasty, knee revision arthoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revision surgery after knee arthroplasty
Our primary outcome measure was if a patient received revision surgery after knee arthroplasty (yes/no).
We categorized the reason for revision in a consensus meeting among the investigators from this research group and experts in the Orthopaedic Surgery field into the following categories:
- Clear reason for revision (patellar dislocation, insert wear, fracture, loosening and second stage revision after removal of knee arthroplasty)
- Less clear reason for revision (infection, malalignment and instability)
- Revision performed for unexplained symptoms without important pathophysiology (patellar pain, arthrofibrosis or progression of osteoarthritis (in case of unicondylar knee arthroplasty)).
Measured: Duration until surgery, an average of 2.05 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start1 Jan 2014
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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 Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 70,754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rwpoolman, Leiden University Medical Center
- Investigators
- Rudolf Poolman, Prof, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105646
- Sponsor's protocol ID
- W.20.018)
- Status last verified
- Oct 2021
- First submitted
- 3 May 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will derive data of patients undergoing primary knee arthroplasty from the Dutch Arthroplasty Register, the "Landelijke Registratie Orthopedische Implantaten" (LROI). We have submitted a research application to use data of the LROI for our study, which was judged by the "Wetenschappelijke Adviesraad" (WAR). After approval af the WAR, further agreements have been made between our research group and the LROI about the way in which the data were securely prepared. The specific dataset for our research question was prepared by the LROI and labeled by a specific research number (LROI2020-057 Poolman - Depressie en pijn bij KA). The LROI does not include names and addresses of patients. The citizen service number is encrypted by the LROI. The researchers will have no access to identifiable patient data.
Publications
Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
PubMed 22398175Spekenbrink-Spooren A, Van Steenbergen LN, Denissen GAW, Swierstra BA, Poolman RW, Nelissen RGHH. Higher mid-term revision rates of posterior stabilized compared with cruciate retaining total knee arthroplasties: 133,841 cemented arthroplasties for osteoarthritis in the Netherlands in 2007-2016. Acta Orthop. 2018 Dec;89(6):640-645. doi: 10.1080/17453674.2018.1518570. Epub 2018 Oct 23.
PubMed 30350747Labek G, Thaler M, Janda W, Agreiter M, Stockl B. Revision rates after total joint replacement: cumulative results from worldwide joint register datasets. J Bone Joint Surg Br. 2011 Mar;93(3):293-7. doi: 10.1302/0301-620X.93B3.25467.
PubMed 21357948Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394.
PubMed 20798443Ferket BS, Feldman Z, Zhou J, Oei EH, Bierma-Zeinstra SM, Mazumdar M. Impact of total knee replacement practice: cost effectiveness analysis of data from the Osteoarthritis Initiative. BMJ. 2017 Mar 28;356:j1131. doi: 10.1136/bmj.j1131.
PubMed 28351833Tolk JJ, Waarsing JEH, Janssen RPA, van Steenbergen LN, Bierma-Zeinstra SMA, Reijman M. Development of Preoperative Prediction Models for Pain and Functional Outcome After Total Knee Arthroplasty Using The Dutch Arthroplasty Register Data. J Arthroplasty. 2020 Mar;35(3):690-698.e2. doi: 10.1016/j.arth.2019.10.010. Epub 2019 Oct 18.
PubMed 31711805Choi YJ, Ra HJ. Patient Satisfaction after Total Knee Arthroplasty. Knee Surg Relat Res. 2016 Mar;28(1):1-15. doi: 10.5792/ksrr.2016.28.1.1. Epub 2016 Feb 29.
PubMed 26955608van de Water RB, Leichtenberg CS, Nelissen RGHH, Kroon HM, Kaptijn HH, Onstenk R, Verdegaal SHM, Vliet Vlieland TPM, Gademan MGJ. Preoperative Radiographic Osteoarthritis Severity Modifies the Effect of Preoperative Pain on Pain/Function After Total Knee Arthroplasty: Results at 1 and 2 Years Postoperatively. J Bone Joint Surg Am. 2019 May 15;101(10):879-887. doi: 10.2106/JBJS.18.00642.
PubMed 31094979Bierke S, Haner M, Petersen W. Influence of somatization and depressive symptoms on the course of pain within the first year after uncomplicated total knee replacement: a prospective study. Int Orthop. 2016 Jul;40(7):1353-60. doi: 10.1007/s00264-015-3105-z. Epub 2016 Jan 28.
PubMed 26820743Bistolfi A, Bettoni E, Aprato A, Milani P, Berchialla P, Graziano E, Massazza G, Lee GC. The presence and influence of mild depressive symptoms on post-operative pain perception following primary total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2792-2800. doi: 10.1007/s00167-015-3737-y. Epub 2015 Sep 21.
PubMed 26392343Duivenvoorden T, Vissers MM, Verhaar JA, Busschbach JJ, Gosens T, Bloem RM, Bierma-Zeinstra SM, Reijman M. Anxiety and depressive symptoms before and after total hip and knee arthroplasty: a prospective multicentre study. Osteoarthritis Cartilage. 2013 Dec;21(12):1834-40. doi: 10.1016/j.joca.2013.08.022. Epub 2013 Sep 4.
PubMed 24012622Ellis HB, Howard KJ, Khaleel MA, Bucholz R. Effect of psychopathology on patient-perceived outcomes of total knee arthroplasty within an indigent population. J Bone Joint Surg Am. 2012 Jun 20;94(12):e84. doi: 10.2106/JBJS.K.00888.
PubMed 22717836Konig HH, Born A, Gunther O, Matschinger H, Heinrich S, Riedel-Heller SG, Angermeyer MC, Roick C. Validity and responsiveness of the EQ-5D in assessing and valuing health status in patients with anxiety disorders. Health Qual Life Outcomes. 2010 May 5;8:47. doi: 10.1186/1477-7525-8-47.
PubMed 20444251Khatib Y, Jenkin D, Naylor JM, Harris IA. Psychological Traits in Patients Waiting for Total Knee Arthroplasty. A Cross-sectional Study. J Arthroplasty. 2016 Aug;31(8):1661-6. doi: 10.1016/j.arth.2016.01.053. Epub 2016 Feb 8.
PubMed 26944015Geisser ME, Roth RS, Theisen ME, Robinson ME, Riley JL 3rd. Negative affect, self-report of depressive symptoms, and clinical depression: relation to the experience of chronic pain. Clin J Pain. 2000 Jun;16(2):110-20. doi: 10.1097/00002508-200006000-00004.
PubMed 10870723
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Preoperative Perception of Pain and Psychological Distress Before Primary Knee Arthroplasty Associated With Reason for Revision Surgery? Results of an Observational Study From the Dutch Arthroplasty Register.
- ClinicalTrials.gov ID
- NCT05105646
- Acronym / sponsor ID
- W.20.018)
- Conditions
- Osteo Arthritis Knee, Psychological Distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70,754 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 3 Nov 2021 (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.
The aim of our study is to identify the influence of preoperative pain (NRS pain score and EQ5D pain score) and higher levels of anxiety and depression (EQ5D anxiety/depression score) and their interaction before primary total knee arthroplasty on revision surgery for unexplained symptoms after primary surgery.
Detailed description
Knee arthroplasty can decrease pain and improve function in people with advanced osteoarthritis of the knee. It is a common procedure; over 25,000 primary knee arthroplasties are performed in the Netherlands each year[2]. A primary knee arthroplasty is defined as the first implantation of a prosthesis in the knee. Revision surgery is defined as any exchange (placement, replacement, or removal) or addition of 1 or more components of the prosthesis (e.g. patella resurfacing)[3]. About 12% of knee arthroplasties are revised within 10 years.
It is known that 1 in 5 patients rate themselves categorically dissatisfied after knee arthroplasty (the so-called unhappy knee). It seems sensible that the percentage of patients that has some dissatisfaction with their knee arthroplasty is likely much larger. After knee arthroplasty, some patients receive revision surgery based on clear reasons such as periprosthetic fracture and patellar dislocation, while in some patients that are dissatisfied revision surgery might be considered for less clear reasons such as a small technical issue, for a perceived technical issue, or with the idea that there is a low grade infection. Understanding the preoperative factors of postoperative pain and functional impairment, leading to dissatisfaction, may help to inform patients considering primary knee arthroplasty about the risk of revision surgery. Although pain and function of patients with higher preoperative pain scores before primary knee arthroplasty will improve as much as the scores of patients with lower preoperative pain scores, their final postoperative pain levels and function will remain inferior compared to patients with lower preoperative pain scores. Higher levels of anxiety and symptoms of depression before knee arthroplasty have also been related to worse postoperative patient reported outcome measures after surgery. Furthermore, the experience of pain and symptoms of depression are closely related to each other and they may influence each other in a bidirectional way. Determining the influence of preoperative pain and psychological distress (anxiety/depression) and their interaction on postoperative outcome seems to be crucial because mental and social health opportunities might be underdiagnosed and undertreated and the indication for a revision surgery may be based on a misdiagnosis of perceived or actual pathophysiology or technical deficiency in patients without a clear technical or medical indication for revision.
The aim of this study is to identify the influence of the preoperative pain (NRS pain score and EQ5D pain score) and higher levels of anxiety and depression (EQ5D anxiety/depression score) and their association before primary total knee arthroplasty (TKA) on revision surgery for unexplained symptoms after primary surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Procedure: Knee Arthroplasty, knee revision arthoplasty• All patients undergoing primary total knee arthroplasty for osteoarthritis of the knee reported in the Dutch Arthroplasty Register. and • Patients who filled out the EQ-5D-3L anxiety/depression score. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary knee arthroplasty (e.g., total, unicondylar and patellofemoral) reported in the Dutch Arthroplasty Register.
Key inclusion criteria (2 listed)
- All patients undergoing primary knee arthroplasty (e.g., total, unicondylar and patellofemoral) reported in the Dutch Arthroplasty Register.
- Patients who filled out the NRS pain score, EQ-5D 3L or EQ-5D 5L pain score or EQ-5D anxiety/depression score.
Key exclusion criteria (2 listed)
- Other types of (revision) arthroplasty (hip / shoulder / ankle)
- Patients who did not fill out the NRS pain score, EQ-5D (3L or 5L) pain score or EQ-5D (3L or 5L) anxiety/depression score
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 |
|---|---|---|
| Knee Arthroplasty, knee revision arthoplastyPrimary knee arthroplasty (e.g., total, unicondylar and patellofemoral) | Procedure or surgery | Patients |
Primary outcome
Revision surgery after knee arthroplasty
Time frame: Duration until surgery, an average of 2.05 years.
Our primary outcome measure was if a patient received revision surgery after knee arthroplasty (yes/no). We categorized the reason for revision in a consensus meeting among the investigators from this research group and experts in the Orthopaedic Surgery field into the following categories: * Clear reason for revision (patellar dislocation, insert wear, fracture, loosening and second stage revision after removal of knee arthroplasty) * Less clear reason for revision (infection, malalignment and instability) * Revision performed for unexplained symptoms without important pathophysiology (patellar pain, arthrofibrosis or progression of osteoarthritis (in case of unicondylar knee arthroplasty)).
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 3 Nov 2021.
- Background: PubMed 22398175Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.
- Background: PubMed 30350747Spekenbrink-Spooren A, Van Steenbergen LN, Denissen GAW, Swierstra BA, Poolman RW, Nelissen RGHH. Higher mid-term revision rates of posterior stabilized compared with cruciate retaining total knee arthroplasties: 133,841 cemented arthroplasties for osteoarthritis in the Netherlands in 2007-2016. Acta Orthop. 2018 Dec;89(6):640-645. doi: 10.1080/17453674.2018.1518570. Epub 2018 Oct 23.
- Background: PubMed 21357948Labek G, Thaler M, Janda W, Agreiter M, Stockl B. Revision rates after total joint replacement: cumulative results from worldwide joint register datasets. J Bone Joint Surg Br. 2011 Mar;93(3):293-7. doi: 10.1302/0301-620X.93B3.25467.
- Background: PubMed 20798443Scott CE, Howie CR, MacDonald D, Biant LC. Predicting dissatisfaction following total knee replacement: a prospective study of 1217 patients. J Bone Joint Surg Br. 2010 Sep;92(9):1253-8. doi: 10.1302/0301-620X.92B9.24394.
- Background: PubMed 28351833Ferket BS, Feldman Z, Zhou J, Oei EH, Bierma-Zeinstra SM, Mazumdar M. Impact of total knee replacement practice: cost effectiveness analysis of data from the Osteoarthritis Initiative. BMJ. 2017 Mar 28;356:j1131. doi: 10.1136/bmj.j1131.
- Background: PubMed 31711805Tolk JJ, Waarsing JEH, Janssen RPA, van Steenbergen LN, Bierma-Zeinstra SMA, Reijman M. Development of Preoperative Prediction Models for Pain and Functional Outcome After Total Knee Arthroplasty Using The Dutch Arthroplasty Register Data. J Arthroplasty. 2020 Mar;35(3):690-698.e2. doi: 10.1016/j.arth.2019.10.010. Epub 2019 Oct 18.
- Background: PubMed 26955608Choi YJ, Ra HJ. Patient Satisfaction after Total Knee Arthroplasty. Knee Surg Relat Res. 2016 Mar;28(1):1-15. doi: 10.5792/ksrr.2016.28.1.1. Epub 2016 Feb 29.
- Background: PubMed 31094979van de Water RB, Leichtenberg CS, Nelissen RGHH, Kroon HM, Kaptijn HH, Onstenk R, Verdegaal SHM, Vliet Vlieland TPM, Gademan MGJ. Preoperative Radiographic Osteoarthritis Severity Modifies the Effect of Preoperative Pain on Pain/Function After Total Knee Arthroplasty: Results at 1 and 2 Years Postoperatively. J Bone Joint Surg Am. 2019 May 15;101(10):879-887. doi: 10.2106/JBJS.18.00642.
- Background: PubMed 26820743Bierke S, Haner M, Petersen W. Influence of somatization and depressive symptoms on the course of pain within the first year after uncomplicated total knee replacement: a prospective study. Int Orthop. 2016 Jul;40(7):1353-60. doi: 10.1007/s00264-015-3105-z. Epub 2016 Jan 28.
- Background: PubMed 26392343Bistolfi A, Bettoni E, Aprato A, Milani P, Berchialla P, Graziano E, Massazza G, Lee GC. The presence and influence of mild depressive symptoms on post-operative pain perception following primary total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2792-2800. doi: 10.1007/s00167-015-3737-y. Epub 2015 Sep 21.
- Background: PubMed 24012622Duivenvoorden T, Vissers MM, Verhaar JA, Busschbach JJ, Gosens T, Bloem RM, Bierma-Zeinstra SM, Reijman M. Anxiety and depressive symptoms before and after total hip and knee arthroplasty: a prospective multicentre study. Osteoarthritis Cartilage. 2013 Dec;21(12):1834-40. doi: 10.1016/j.joca.2013.08.022. Epub 2013 Sep 4.
- Background: PubMed 22717836Ellis HB, Howard KJ, Khaleel MA, Bucholz R. Effect of psychopathology on patient-perceived outcomes of total knee arthroplasty within an indigent population. J Bone Joint Surg Am. 2012 Jun 20;94(12):e84. doi: 10.2106/JBJS.K.00888.
- Reference 2 LROI 2019. LROI Report 2019 \[Internet\]. \[cited 2020 Feb 11\].Link provided by the sponsor.
- Individual participant dataSharing planned: No. We will derive data of patients undergoing primary knee arthroplasty from the Dutch Arthroplasty Register, the "Landelijke Registratie Orthopedische Implantaten" (LROI). We have submitted a research application to use data of the LROI for our study, which was judged by the "Wetenschappelijke Adviesraad" (WAR). After approval af the WAR, further agreements have been made between our research group and the LROI about the way in which the data were securely prepared. The specific dataset for our research question was prepared by the LROI and labeled by a specific research number (LROI2020-057 Poolman - Depressie en pijn bij KA). The LROI does not include names and addresses of patients. The citizen service number is encrypted by the LROI. The researchers will have no access to identifiable patient data.
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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.
Rudolf Poolman, Prof principal investigator
LUMC
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 Osteo Arthritis Knee and Psychological Distress, run by Leiden University Medical Center at 1 site in Netherlands.
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 2 inclusion and 2 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 3 Nov 2021. 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 Netherlands. 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?
Revision surgery after knee arthroplasty (time frame: Duration until surgery, an average of 2.05 years.). 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 NCT05105646, 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 3 Nov 2021.