Biological Link Between Anxiety and Outcomes Post Knee Arthroplasty

NCT07102563 | Not Yet Recruiting

• 1 other identifier: RL1 914
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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. 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

1. 1.Preoperative phase (routine clinic visit):
2. 2.Day of surgery:
3. 3.Postoperative follow-up:

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  For the first 6 months following TKR or THR surgery.

Study Arms (4)

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)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Total knee replacement (TKR) or total hip replacement (THR) patients.

You may qualify if:

• 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

You may not qualify if:

• Rheumatoid arthritis or inflammatory arthropathies.
• Patients on Steroids, Aspirin, or Cox inhibitors.
• Smokers or vapers.

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

Study Sites (1)

The Robert Jones and Agnes Hunt Orthopaedic Hospital

Oswestry, Shropshire, SY10 7AG, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 21846588 BACKGROUND

• Bourne 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.

  PMID: 19844772 BACKGROUND

• Nam 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.

  PMID: 25381418 BACKGROUND

• Scott 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.

  PMID: 20798443 BACKGROUND

• DeFrance 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.

  PMID: 36252743 BACKGROUND

• Anakwe 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.

  PMID: 20462736 BACKGROUND

• Versus Arthritis. Tackling osteoarthritis - the UK's leading cause of pain and disability. Versus Arthritis. 2021.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue

Central Study Contacts

Julie Steen

CONTACT

+441691404418; julie.steen@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)