NCT03064334

Brief Summary

In order to assess patients' concerns and other quality of life aspects, post-total knee arthroplasty (TKA) requires further assessment tools, more than controlled experiments testing defined isolated variables. Qualitative research offers useful methods to explicate the complexity and deeper meaning of patient experiences and outcomes post-TKA. Qualitative methods facilitate the collection of in-depth experiences and perceptions from individuals about a specific phenomenon which, in this case, is outcomes post-TKA. Specifically, a phenomenological approach allows for the collection of diverse and unique patient experiences and outcomes post-TKA . The focus of this project is using focus groups to explore poorly understood areas, such as outcomes and experiences post-TKA, in order to generate useful findings and hypotheses.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

February 15, 2017

Last Update Submit

May 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Medium focus groups discussion to explore the patients experiance and functional recovery post -TKA.

    Qualitative methods in term of medium focus groups discussion will be used to explore the patients perceptions and experiences post-surgery. The focus groups will be facilitated by a focus-group expert and the researcher using open-ended questions in order to prompt free discussion to explore their experience and barrier post-TKA. All topics and questions covered will be suitable to discuss in a semi-public setting. All discussions will be recorded using electronic methods, in addition to field notes taken by both facilitator and researcher. Discussion guide: How was experience of Total Knee Arthroplasty (TKA), Functional improvements after TKA, What modifications have been made to compensate for that, What are the barrier, In the course of routine activities did the patients need help, Did the patients need family support, Were patients able return to work after TKA, (if not, why? what are the barriers

    60 -70 minute of total 120 minute of focus group discussion.

Secondary Outcomes (1)

  • Medium focus groups discussion to explore the quality of health service provide post -TKA

    40 -50 minute of total 120 minute of focus group discussion.

Study Arms (1)

one medium of focus groups

The present study aims to understand patient experiences and outcomes post- Total Knee Arthroplasty(TKA). Therefore, a qualitative approach will be most appropriate to facilitate the collection of in-depth experiences and perceptions of patients post-TKA. The medium of focus groups (with 8-10 patients) is preferred to allow a group of patients to share their perceptions and experiences post-surgery, with sufficient quantity and diversity of views while balancing the facilitator's ability to manage all patients' participation for 90-120 minutes (Bloor, 2006).

Procedure: Total Knee Arthroplasty

Interventions

surgical knee joints Arthroplasty

Also known as: Total Knee Replacement surgery
one medium of focus groups

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The participants will be recruited at Stepping Hill Hospital. Sample criteria require will be clarified for all three orthopaedic surgeons at the hospital. Any patients attending for a one-year follow-up visit who are willing to participate in a focus-group study will be included in a research-patients list. A participant information sheet and an informed consent form will be sent via Royal Mail or email to each participant four weeks before the study to allow participants to consider their involvement in the study and have the time to decide whether or not to contribute. They will be able to change their minds on the day should they wish to do so.

You may qualify if:

  • Patients who have undergone primary unilateral total knee arthroplasty within the last year.
  • Maximum post-operative achievement is between one and two years.
  • Patients can read and understand English, non-English speaking patients will be excluded from the study to avoid any language barrier.
  • Purposive sampling will be used to recruit the most relevant patients to answer the research questions such as;
  • mixed genders to explore gender-experience differences.
  • mixed work and retired to explore return to work barriers
  • patients with family support and patients living alone to explore the value of family support or home-care services
  • mixed educational levels to explore educational background effects.
  • So there will be no age, gender, social, work status or educational level limitations (Schwandt, 2001)

You may not qualify if:

  • There are possible complications or they present with other pathological conditions that might change recovery progression, they will be excluded to minimize confounding factors and their effects on patients' experiences and outcomes, such as:
  • They have undergone bilateral knee arthroplasty, unilateral knee revision surgery, post-traumatic or unicompartmental knee replacement.
  • They cannot read and understand English.
  • Their function is limited due to musculoskeletal involvements other than unilateral knee osteoarthritis.
  • They have been diagnosed with uncontrolled diabetes mellitus or blood pressure.
  • Post-TKR they are in pathological groups, such as having neurological disorders (stroke, Parkinson's disease etc.), haemophilia or psychological pathologies.
  • They are morbidly obese and have a body mass index (BMI) greater than 40.
  • They have advanced osteoporosis or some other unstable chronic disease.
  • They have been diagnosed with peripheral vascular disease or an uncontrolled cardiac disease.
  • They present with major postoperative complications, such as infection, fracture, acute myocardial infarction, stroke, pulmonary embolism or deep-vein thrombosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stockport NHS Foundation Trust

Stockport, Manchester, SK2 7JE, United Kingdom

Location

Related Publications (20)

  • Attride-Stirling, J. (2001). Thematic networks: an analytic tool for qualitative research. Qualitative Research, 1(3), 385-405. doi:10.1177/146879410100100307

    BACKGROUND
  • Beaton DE, Clark JP. Qualitative research: a review of methods with use of examples from the total knee replacement literature. J Bone Joint Surg Am. 2009 May;91 Suppl 3:107-12. doi: 10.2106/JBJS.H.01631.

    PMID: 19411508BACKGROUND
  • Bloor, M., and Wood, F. (2006). Keywords in Qualitative Methods. A Vocabulary of Research Methods. London: SAGE Publications Ltd.

    BACKGROUND
  • 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.

    PMID: 22398175BACKGROUND
  • Hossain FS, Konan S, Patel S, Rodriguez-Merchan EC, Haddad FS. The assessment of outcome after total knee arthroplasty: are we there yet? Bone Joint J. 2015 Jan;97-B(1):3-9. doi: 10.1302/0301-620X.97B1.34434.

    PMID: 25568406BACKGROUND
  • Jagger, C., Matthews, R., Spiers, N., Brayne, C., Comas - Herrera, A., Robinson, T., . . . Croft, P. (2006). Compression or expansion of disability?: forecasting future disability levels under changing patterns of diseases: King's Fund.

    BACKGROUND
  • Kitzinger J. Qualitative research. Introducing focus groups. BMJ. 1995 Jul 29;311(7000):299-302. doi: 10.1136/bmj.311.7000.299.

    PMID: 7633241BACKGROUND
  • Klit J, Jacobsen S, Rosenlund S, Sonne-Holm S, Troelsen A. Total knee arthroplasty in younger patients evaluated by alternative outcome measures. J Arthroplasty. 2014 May;29(5):912-7. doi: 10.1016/j.arth.2013.09.035. Epub 2013 Oct 1.

    PMID: 24269097BACKGROUND
  • Lehoux P, Poland B, Daudelin G. Focus group research and "the patient's view". Soc Sci Med. 2006 Oct;63(8):2091-104. doi: 10.1016/j.socscimed.2006.05.016. Epub 2006 Jun 23.

    PMID: 16797811BACKGROUND
  • Ong BN, Richardson JC. The contribution of qualitative approaches to musculoskeletal research. Rheumatology (Oxford). 2006 Apr;45(4):369-70. doi: 10.1093/rheumatology/kel022. Epub 2006 Jan 25. No abstract available.

    PMID: 16436487BACKGROUND
  • Palomba, C. A., & Banta, T. W. (1999). Assessment essentials : planning, implementing, and improving assessment in higher education. San Francisco: Jossey-Bass Publishers.

    BACKGROUND
  • Patel A, Pavlou G, Mujica-Mota RE, Toms AD. The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone Joint J. 2015 Aug;97-B(8):1076-81. doi: 10.1302/0301-620X.97B8.35170.

    PMID: 26224824BACKGROUND
  • Rastogi R, Davis AM, Chesworth BM. A cross-sectional look at patient concerns in the first six weeks following primary total knee arthroplasty. Health Qual Life Outcomes. 2007 Aug 1;5:48. doi: 10.1186/1477-7525-5-48.

    PMID: 17678532BACKGROUND
  • Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995 Apr;18(2):179-83. doi: 10.1002/nur.4770180211.

    PMID: 7899572BACKGROUND
  • Schwandt, T. (2001). Dictionary of Qualitative Inquiry: Thousand Oaks Ca: Sage.

    BACKGROUND
  • Sim, J., & Snell, J. (1996). Focus groups in physiotherapy evaluation and research. Physiotherapy, 82(3), 189-198.

    BACKGROUND
  • van Egmond JC, Verburg H, Vehmeijer SB, Mathijssen NM. Early follow-up after primary total knee and total hip arthroplasty with rapid recovery : Focus groups. Acta Orthop Belg. 2015 Sep;81(3):447-53.

    PMID: 26435240BACKGROUND
  • Westby MD, Backman CL. Patient and health professional views on rehabilitation practices and outcomes following total hip and knee arthroplasty for osteoarthritis:a focus group study. BMC Health Serv Res. 2010 May 11;10:119. doi: 10.1186/1472-6963-10-119.

    PMID: 20459834BACKGROUND
  • Williams DP, Blakey CM, Hadfield SG, Murray DW, Price AJ, Field RE. Long-term trends in the Oxford knee score following total knee replacement. Bone Joint J. 2013 Jan;95-B(1):45-51. doi: 10.1302/0301-620X.95B1.28573.

    PMID: 23307672BACKGROUND
  • Zacharia B, Paul M, Thanveeruddin Sherule M. Patient-based outcome analysis is important to determine the success of total knee arthroplasty: result of a focus group discussion. Med Devices (Auckl). 2016 May 23;9:125-30. doi: 10.2147/MDER.S97094. eCollection 2016.

    PMID: 27284268BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Professor Richard Professor Jones

    Director of the Salford University Gait Laboratory

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 27, 2017

Study Start

January 1, 2018

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

May 3, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations