Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patients' Views on Outcomes Following Total Knee Arthroplasty: a Focus-group Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03064334
Recruitment Status : Completed
First Posted : February 27, 2017
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Stockport NHS Foundation Trust
Information provided by (Responsible Party):
Bodor Bin sheeha, University of Salford

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.


Condition or disease Intervention/treatment
Total Knee Arthroplasty Procedure: Total Knee Arthroplasty

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Other
Time Perspective: Other
Official Title: Patients' Views on Outcomes Following Total Knee Arthroplasty: a Focus-group Study
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
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
surgical knee joints Arthroplasty
Other Name: Total Knee Replacement surgery




Primary Outcome Measures :
  1. Medium focus groups discussion to explore the patients experiance and functional recovery post -TKA. [ Time Frame: 60 -70 minute of total 120 minute of focus group discussion. ]

    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



Secondary Outcome Measures :
  1. Medium focus groups discussion to explore the quality of health service provide post -TKA [ Time Frame: 40 -50 minute of total 120 minute of focus group discussion. ]
    The secondary outcome from the focus group discussion will Evaluate the health service quality using the following questions; How did the patients feel about the surgery now? Did patients satisfy all their expectations, Did they receive sufficient information and explanation about surgery and expectations in advance from the health team, Was that sufficient for what they needed to know before surgery, Do patient think that has affected their satisfaction after surgery, Have they received physiotherapy post-surgery. For how long How many sessions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064334


Locations
Layout table for location information
United Kingdom
Stockport NHS Foundation Trust
Stockport, Manchester, United Kingdom, SK2 7JE
Sponsors and Collaborators
University of Salford
Stockport NHS Foundation Trust
Investigators
Layout table for investigator information
Study Director: Professor Richard Professor Jones Director of the Salford University Gait Laboratory

Publications:
Attride-Stirling, J. (2001). Thematic networks: an analytic tool for qualitative research. Qualitative Research, 1(3), 385-405. doi:10.1177/146879410100100307
Bloor, M., and Wood, F. (2006). Keywords in Qualitative Methods. A Vocabulary of Research Methods. London: SAGE Publications Ltd.
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.
Palomba, C. A., & Banta, T. W. (1999). Assessment essentials : planning, implementing, and improving assessment in higher education. San Francisco: Jossey-Bass Publishers.
Schwandt, T. (2001). Dictionary of Qualitative Inquiry: Thousand Oaks Ca: Sage.
Sim, J., & Snell, J. (1996). Focus groups in physiotherapy evaluation and research. Physiotherapy, 82(3), 189-198.

Layout table for additonal information
Responsible Party: Bodor Bin sheeha, PhD student, University of Salford
ClinicalTrials.gov Identifier: NCT03064334     History of Changes
Other Study ID Numbers: qualitative
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No