Total Knee ArthroplastyNCT07102563
Biological Link Between Anxiety and Outcomes Post Knee Arthroplasty
An observational study of Total Knee Arthroplasty, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
This is a single-site, observational pilot study that aims to understand whether there is a biological explanation for why some patients with anxiety or depression experience poorer outcomes after total knee or hip replacement surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2025to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total knee replacement (TKR) or total hip replacement (THR) patients.
Who may be able to join
- Aged 18 years or older.
- Scheduled to undergo elective total knee replacement (TKR) or total hip replacement (THR) at the Robert Jones and Agnes Hunt Orthopaedic Hospital.
- Body mass index (BMI) less than 35
Who cannot join
- Rheumatoid arthritis or inflammatory arthropathies.
- Patients on Steroids, Aspirin, or Cox inhibitors.
- Smokers or vapers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
The Robert Jones and Agnes Hunt Orthopaedic Hospital
Oswestry, Shropshire, SY10 7AG
Julie Steen, +441691404418 ext. 4418, julie.steen@nhs.net
Jayne Edwards
About this study
Official title: Investigating the Biological Link Between Mental Health Status and Outcomes Following Total Knee and Hip Replacement.
This is a single-site, observational pilot study that aims to understand whether there is a biological explanation for why some patients with anxiety or depression experience poorer outcomes after total knee or hip replacement surgery. The study investigates the role of inflammation inside the joint, using tissue, fluid, and blood samples collected during routine care, alongside patient-reported outcome questionnaires.
Study Design and Hypothesis The hypothesis is that patients with pre-existing anxiety or depression will show more inflammation in their joint tissue or blood, and that this may be linked to poorer functional outcomes after surgery. An alternative explanation is that these patients may report worse outcomes without an identifiable biological cause.
Read more
The study does not involve any trial drugs or new treatments and does not use a placebo or randomisation.
Patients will be grouped based on whether or not they meet the criteria for anxiety and/or depression as measured by two validated mental health screening tools:
GAD-7 (for anxiety)
PHQ-8 (for depression)
Sampling and Participant Involvement:
The plan is to include 56 patients, equally split between hip and knee replacement groups, and between those with and without anxiety/depression (14 per subgroup). Participants will be identified by the clinical research team from the waiting lists of two lead surgeons and approached by post and phone before their routine preoperative assessment clinic.
At that appointment, consent will be obtained and the participant will complete baseline questionnaires. The same questionnaires will be repeated at 3 and 6 months postoperatively. No additional visits will be required.
Study Procedures and Timeline
- Preoperative phase (routine clinic visit): Participants are posted a cover letter, patient information sheet, and consent form ahead of their clinic visit. A member of the research team calls the patient to explain the study. At the clinic, a research nurse obtains informed consent. Participants complete baseline questionnaires assessing pain, quality of life, and mental wellbeing (e.g. Oxford score, EQ-5D, PHQ-8, GAD-7).
- Day of surgery: An additional 20 ml of blood is collected at the same time as routine preoperative blood tests, using the same venepuncture. While under anaesthetic, the operating surgeon collects small tissue samples (synovial fluid, synovial tissue, and fat) from the joint. These samples are normally discarded as part of the operation. Samples are anonymised and sent to pathology and research laboratories for analysis.
- Postoperative follow-up:
At the 3-month clinic visit (routine care), participants complete the same questionnaires and provide a further blood sample of approximately 15 ml.
At 6 months, questionnaires are completed remotely via the MyRecovery app, with no further hospital visit or samples required.
All study procedures are aligned with routine NHS care to minimise burden. There are no additional clinic visits required.
Data Handling and Analysis The study will compare inflammation levels (in blood and tissue) between groups and analyse how these relate to patient-reported outcomes. All data will be anonymised. Blood samples will be processed at local NHS labs (Shrewsbury) and at a specialist centre in Sheffield for specific inflammatory markers (e.g. IL-6, CD solubles). Synovial tissue will be histologically analysed on-site for synovitis.
Read the detailed description
This study aims to investigate the potential biological mechanisms linking preoperative anxiety and depression with poorer patient-reported outcomes following total knee or hip replacement surgery. Specifically, we are exploring whether psychological distress is associated with increased local joint inflammation (synovitis) and whether this may mediate reduced functional recovery. Biological samples (including synovial fluid, synovial tissue, and fat pad) will be collected intraoperatively from routine surgical waste, and additional blood samples will be analysed for routine blood tests (FBC, Renal function tests, Liver function tests) and inflammatory markers (CRP, ESR, IL-6, CD solubles). We will correlate these findings with validated psychological and functional outcome measures collected pre- and postoperatively.
Recruitment and Consent:
Patients scheduled for elective knee or hip replacement at the Robert Jones and Agnes Hunt Orthopaedic Hospital will be screened for eligibility by a clinician as part of the care team. Eligible patients will receive a patient information sheet and consent form by post ahead of their routine preoperative clinic visit. A telephone call will follow to confirm interest. Final written informed consent will be obtained by a trained research nurse at the preoperative assessment clinic. Participants may decline or withdraw from the study at any time without affecting their standard clinical care.
Risks, Burdens, and Benefits:
The risks associated with participation are minimal. All tissue samples will be collected during routine surgery while the patient is under general anaesthesia, using tissue that would otherwise be discarded. A small additional blood sample (20 ml) will be collected on the day of surgery using the same venepuncture as for routine bloods, and a follow-up sample (approx. 15 ml) will be withdrawn at the routine 3-month clinic visit. The risks of blood withdrawal are minimal such as discomfort or bruising. However, a senior trained staff will withdraw all the blood tests to minimise any potential risks. Questionnaires on anxiety and depression might cause mild emotional discomfort; appropriate safeguarding procedures are in place, and GP referrals will be made for participants scoring above clinical thresholds. Participants will be informed of their blood test results related to inflammation, where clinically appropriate.
Confidentiality and Data Security:
All identifiable information will be stored securely, in accordance with the Data Protection Act 1998 and current NHS policies. Each participant will be assigned a unique study ID. Identifiable data will be kept separate from research data and stored in encrypted, password-protected files. Only authorised research staff will have access. Biological samples sent for external analysis (IL-6 and CD solubles in Sheffield Hospital) will be fully anonymised.
Use and Storage of Samples:
The institution holds appropriate approvals under the Human Tissue Act to store and use human biological samples. Any remaining samples may be stored securely in the RJAH Arthritis Research Centre laboratory for future ethically approved research. No genetic testing will be performed. Samples may be transported to partner laboratories within the UK for specific assays, using NHS-compliant logistics.
Ethical and Organisational Oversight:
This is a single-site, low-risk observational study embedded within routine NHS care. There are no additional clinic visits or interventions. Ethical, data protection, and sample handling issues have been reviewed and addressed through standard NHS research governance procedures, and the study has received peer review and 'agreement in principle' from all relevant support departments.
- Conditions
- Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TKR patients with anxiety/depression (14) | TKR patients with anxiety/depression (14) | |
| TKR patients without anxiety/depression (14) | TKR patients without anxiety/depression (14) | |
| THR patients with anxiety/depression (14) | THR patients with anxiety/depression (14) | |
| THR patients without anxiety/depression (14) | THR patients without anxiety/depression (14) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between preoperative anxiety and/or depression following total knee replacement (TKR) versus total hip replacement (THR).
The primary outcome measure is the correlation between preoperative anxiety and/or depression (measured by validated mental health questionnaires) and postoperative outcomes (measured by patient-reported outcome measures, or PROMs) following total knee replacement (TKR) versus total hip replacement (THR).
Specifically, the study will assess:
Whether the severity of anxiety or depression is associated with worse PROMs (e.g. Oxford Knee or Hip Score, EQ-5D) at 3 and 6 months after surgery.
Whether this relationship is influenced (mediated) by the presence and severity of synovitis (joint inflammation) and inflammatory cytokines (measured in synovial fluid and blood).
Measured: For the first 6 months following TKR or THR surgery.
Secondary outcomes (1)
Correlation between preoperative anxiety/depression , synovitis grade and inflammatory markers in synovial fluid with systemic inflammation.
Blood biomarkers such as CRP, ESR, IL-6, and CD solubles.
Differences in hospital stay duration, readmission rates, and postoperative complications between:
Patients who report satisfaction versus dissatisfaction after surgery, and Patients with versus without preoperative anxiety/depression, stratified by joint type (total knee replacement vs total hip replacement).
Measured: For the first 6 months following TKR or THR surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies 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
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102563
- Sponsor's protocol ID
- RL1 914
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blackburn J, Qureshi A, Amirfeyz R, Bannister G. Does preoperative anxiety and depression predict satisfaction after total knee replacement? Knee. 2012 Oct;19(5):522-4. doi: 10.1016/j.knee.2011.07.008. Epub 2011 Aug 16.
PubMed 21846588Bourne 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 19844772Nam D, Nunley RM, Barrack RL. Patient dissatisfaction following total knee replacement: a growing concern? Bone Joint J. 2014 Nov;96-B(11 Supple A):96-100. doi: 10.1302/0301-620X.96B11.34152.
PubMed 25381418Scott 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 20798443DeFrance MJ, Scuderi GR. Are 20% of Patients Actually Dissatisfied Following Total Knee Arthroplasty? A Systematic Review of the Literature. J Arthroplasty. 2023 Mar;38(3):594-599. doi: 10.1016/j.arth.2022.10.011. Epub 2022 Oct 14.
PubMed 36252743Anakwe RE, Jenkins PJ, Moran M. Predicting dissatisfaction after total hip arthroplasty: a study of 850 patients. J Arthroplasty. 2011 Feb;26(2):209-13. doi: 10.1016/j.arth.2010.03.013. Epub 2010 May 11.
PubMed 20462736Versus Arthritis. Tackling osteoarthritis - the UK's leading cause of pain and disability. Versus Arthritis. 2021.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Biological Link Between Mental Health Status and Outcomes Following Total Knee and Hip Replacement.
- ClinicalTrials.gov ID
- NCT07102563
- Acronym / sponsor ID
- RL1 914
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 3 Aug 2025 (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.
This is a single-site, observational pilot study that aims to understand whether there is a biological explanation for why some patients with anxiety or depression experience poorer outcomes after total knee or hip replacement surgery. The study investigates the role of inflammation inside the joint, using tissue, fluid, and blood samples collected during routine care, alongside patient-reported outcome questionnaires.
Study Design and Hypothesis The hypothesis is that patients with pre-existing anxiety or depression will show more inflammation in their joint tissue or blood, and that this may be linked to poorer functional outcomes after surgery. An alternative explanation is that these patients may report worse outcomes without an identifiable biological cause.
The study does not involve any trial drugs or new treatments and does not use a placebo or randomisation.
Patients will be grouped based on whether or not they meet the criteria for anxiety and/or depression as measured by two validated mental health screening tools:
GAD-7 (for anxiety)
PHQ-8 (for depression)
Sampling and Participant Involvement:
The plan is to include 56 patients, equally split between hip and knee replacement groups, and between those with and without anxiety/depression (14 per subgroup). Participants will be identified by the clinical research team from the waiting lists of two lead surgeons and approached by post and phone before their routine preoperative assessment clinic.
At that appointment, consent will be obtained and the participant will complete baseline questionnaires. The same questionnaires will be repeated at 3 and 6 months postoperatively. No additional visits will be required.
Study Procedures and Timeline
- Preoperative phase (routine clinic visit): Participants are posted a cover letter, patient information sheet, and consent form ahead of their clinic visit. A member of the research team calls the patient to explain the study. At the clinic, a research nurse obtains informed consent. Participants complete baseline questionnaires assessing pain, quality of life, and mental wellbeing (e.g. Oxford score, EQ-5D, PHQ-8, GAD-7).
- Day of surgery: An additional 20 ml of blood is collected at the same time as routine preoperative blood tests, using the same venepuncture. While under anaesthetic, the operating surgeon collects small tissue samples (synovial fluid, synovial tissue, and fat) from the joint. These samples are normally discarded as part of the operation. Samples are anonymised and sent to pathology and research laboratories for analysis.
- Postoperative follow-up:
At the 3-month clinic visit (routine care), participants complete the same questionnaires and provide a further blood sample of approximately 15 ml.
At 6 months, questionnaires are completed remotely via the MyRecovery app, with no further hospital visit or samples required.
All study procedures are aligned with routine NHS care to minimise burden. There are no additional clinic visits required.
Data Handling and Analysis The study will compare inflammation levels (in blood and tissue) between groups and analyse how these relate to patient-reported outcomes. All data will be anonymised. Blood samples will be processed at local NHS labs (Shrewsbury) and at a specialist centre in Sheffield for specific inflammatory markers (e.g. IL-6, CD solubles). Synovial tissue will be histologically analysed on-site for synovitis.
Detailed description
This study aims to investigate the potential biological mechanisms linking preoperative anxiety and depression with poorer patient-reported outcomes following total knee or hip replacement surgery. Specifically, we are exploring whether psychological distress is associated with increased local joint inflammation (synovitis) and whether this may mediate reduced functional recovery. Biological samples (including synovial fluid, synovial tissue, and fat pad) will be collected intraoperatively from routine surgical waste, and additional blood samples will be analysed for routine blood tests (FBC, Renal function tests, Liver function tests) and inflammatory markers (CRP, ESR, IL-6, CD solubles). We will correlate these findings with validated psychological and functional outcome measures collected pre- and postoperatively.
Recruitment and Consent:
Patients scheduled for elective knee or hip replacement at the Robert Jones and Agnes Hunt Orthopaedic Hospital will be screened for eligibility by a clinician as part of the care team. Eligible patients will receive a patient information sheet and consent form by post ahead of their routine preoperative clinic visit. A telephone call will follow to confirm interest. Final written informed consent will be obtained by a trained research nurse at the preoperative assessment clinic. Participants may decline or withdraw from the study at any time without affecting their standard clinical care.
Risks, Burdens, and Benefits:
The risks associated with participation are minimal. All tissue samples will be collected during routine surgery while the patient is under general anaesthesia, using tissue that would otherwise be discarded. A small additional blood sample (20 ml) will be collected on the day of surgery using the same venepuncture as for routine bloods, and a follow-up sample (approx. 15 ml) will be withdrawn at the routine 3-month clinic visit. The risks of blood withdrawal are minimal such as discomfort or bruising. However, a senior trained staff will withdraw all the blood tests to minimise any potential risks. Questionnaires on anxiety and depression might cause mild emotional discomfort; appropriate safeguarding procedures are in place, and GP referrals will be made for participants scoring above clinical thresholds. Participants will be informed of their blood test results related to inflammation, where clinically appropriate.
Confidentiality and Data Security:
All identifiable information will be stored securely, in accordance with the Data Protection Act 1998 and current NHS policies. Each participant will be assigned a unique study ID. Identifiable data will be kept separate from research data and stored in encrypted, password-protected files. Only authorised research staff will have access. Biological samples sent for external analysis (IL-6 and CD solubles in Sheffield Hospital) will be fully anonymised.
Use and Storage of Samples:
The institution holds appropriate approvals under the Human Tissue Act to store and use human biological samples. Any remaining samples may be stored securely in the RJAH Arthritis Research Centre laboratory for future ethically approved research. No genetic testing will be performed. Samples may be transported to partner laboratories within the UK for specific assays, using NHS-compliant logistics.
Ethical and Organisational Oversight:
This is a single-site, low-risk observational study embedded within routine NHS care. There are no additional clinic visits or interventions. Ethical, data protection, and sample handling issues have been reviewed and addressed through standard NHS research governance procedures, and the study has received peer review and 'agreement in principle' from all relevant support departments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TKR patients with anxiety/depression (14) | – | –TKR patients with anxiety/depression (14) |
| TKR patients without anxiety/depression (14) | – | –TKR patients without anxiety/depression (14) |
| THR patients with anxiety/depression (14) | – | –THR patients with anxiety/depression (14) |
| THR patients without anxiety/depression (14) | – | –THR patients without anxiety/depression (14) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total knee replacement (TKR) or total hip replacement (THR) patients.
Key inclusion criteria (3 listed)
- Aged 18 years or older.
- Scheduled to undergo elective total knee replacement (TKR) or total hip replacement (THR) at the Robert Jones and Agnes Hunt Orthopaedic Hospital.
- Body mass index (BMI) less than 35
Key exclusion criteria (3 listed)
- Rheumatoid arthritis or inflammatory arthropathies.
- Patients on Steroids, Aspirin, or Cox inhibitors.
- Smokers or vapers.
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
The correlation between preoperative anxiety and/or depression following total knee replacement (TKR) versus total hip replacement (THR).
Time frame: For the first 6 months following TKR or THR surgery.
The primary outcome measure is the correlation between preoperative anxiety and/or depression (measured by validated mental health questionnaires) and postoperative outcomes (measured by patient-reported outcome measures, or PROMs) following total knee replacement (TKR) versus total hip replacement (THR). Specifically, the study will assess: Whether the severity of anxiety or depression is associated with worse PROMs (e.g. Oxford Knee or Hip Score, EQ-5D) at 3 and 6 months after surgery. Whether this relationship is influenced (mediated) by the presence and severity of synovitis (joint inflammation) and inflammatory cytokines (measured in synovial fluid and blood).
1 secondary outcome
Correlation between preoperative anxiety/depression , synovitis grade and inflammatory markers in synovial fluid with systemic inflammation.
Time frame: For the first 6 months following TKR or THR surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 21846588Blackburn J, Qureshi A, Amirfeyz R, Bannister G. Does preoperative anxiety and depression predict satisfaction after total knee replacement? Knee. 2012 Oct;19(5):522-4. doi: 10.1016/j.knee.2011.07.008. Epub 2011 Aug 16.
- 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 25381418Nam D, Nunley RM, Barrack RL. Patient dissatisfaction following total knee replacement: a growing concern? Bone Joint J. 2014 Nov;96-B(11 Supple A):96-100. doi: 10.1302/0301-620X.96B11.34152.
- 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 36252743DeFrance MJ, Scuderi GR. Are 20% of Patients Actually Dissatisfied Following Total Knee Arthroplasty? A Systematic Review of the Literature. J Arthroplasty. 2023 Mar;38(3):594-599. doi: 10.1016/j.arth.2022.10.011. Epub 2022 Oct 14.
- Background: PubMed 20462736Anakwe RE, Jenkins PJ, Moran M. Predicting dissatisfaction after total hip arthroplasty: a study of 850 patients. J Arthroplasty. 2011 Feb;26(2):209-13. doi: 10.1016/j.arth.2010.03.013. Epub 2010 May 11.
- BackgroundVersus Arthritis. Tackling osteoarthritis - the UK's leading cause of pain and disability. Versus Arthritis. 2021.
- Individual participant dataSharing planned: No
Related trials for Total Knee Arthroplasty
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
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 Total Knee Arthroplasty, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
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 3 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: opening soon, as of the sponsor's last update on 8 Aug 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Steen (+441691404418 ext. 4418, julie.steen@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between preoperative anxiety and/or depression following total knee replacement (TKR) versus total hip replacement (THR). (time frame: For the first 6 months following TKR or THR surgery.). 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 NCT07102563, which also lists 7 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 8 Aug 2025.