Total Knee ArthroplastyNCT03064334
Patients' Views on Outcomes Following Total Knee Arthroplasty: a Focus-group Study
An observational study of Total Knee Arthroplasty, run by University of Salford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2018to 30 Apr 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Stockport NHS Foundation Trust
Stockport, Manchester, SK2 7JE
About this study
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.
Read the detailed description
Knee osteoarthritis (OA) is a major cause of disability around the world; it is the most common chronic condition in primary care in the UK. By 2030 it is predicted to be the greatest cause of disability in the general population . An effective end-stage treatment for knee OA is knee-replacement surgery, which was first done in the 1970s and 1980s.
In England and Wales, the number of knee-replacement procedures recorded by the National Joint Registry in 2013 was 91,703, which represents an increase of 0.9 % over 2012. The data analysis by the National Joint Registry and the Office of National Statistics suggests that, by 2030, primary Total Knee Arthroplasty (TKA) will increase by 117% from the 2012 level. Subsequently, TKA revision surgeries are expected to increase incrementally by 332%. There is a similar estimation of demand for revision TKA surgeries in the United States; by 2030, they are expected to rise by 601% from the 2005 level. The United States estimation of primary TKA is for growth of 673% from the 2005 level, which is similar to England and Wales's upper-limit projections .
Post-TKA, 75-85% of patients report satisfaction with surgery outcomes, while the remaining 15-25% are dissatisfied .Total knee arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g. the presence of surgical complications or implant survival. This is gradually changing to involve the patient in measuring health outcomes and decision-making processes. Patient-reported outcome measures (PROMs) have evolved to explore patient perspectives by monitoring the quality of care in health organizations and conducting clinical trial outcomes.
More than half of patients' early concerns post-total knee arthroplasty (TKA) are not considered in commonly used patient-reported outcome measures . This may support current medical outcomes evaluation post-TKA having implications that differ from the patient perspective. This may be explained by the dissatisfaction of some patients post-TKA. So, being more sensitive to patient experience assessment methods is required, rather than profession-driven tools.
Patients' experiences and their perceptions of current outcome measurements post-TKA are poorly understood. In order to explore this area qualitative methods are appropriate, as they facilitate the collection of in-depth experiences and perceptions of 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.
A focus group is useful for exploring poorly understood areas, such as outcomes and experiences post-TKA, in order to generate possible findings or hypotheses. It has advantages over one-to-one interviews as the interaction among group members provides an extra dimension to gather data and a wider degree of spontaneity in the patient views expressed, in contrast to one-to-one interviews where the interaction is limited to that between patients and researcher and depends on patient responses. Interaction in a group setting allows patients to refine their views in light of others' views and facilitates further spontaneous expression. Support for the feelings of other group members with similar experiences encourages less verbal individuals to contribute more than in one-to-one interviews.
Only three previous studies have used focus-group methods to explore patient experiences post-TKA. Studies by Westby et al. (2010) and Van Egmond et al. (2015) combined the results of patient experiences post-total knee arthroplasty and post-total hip arthroplasty, which does not support accuracy as those patient groups encounter different problems. The third study, by Zacharia et al. (2016), assessed outcomes at least three years post-TKA in a limited age range of 60-65 years for manual labourers of low and medium socioeconomic status. An appropriate well-structured methodology is required to explore patient experiences and outcomes post-TKA, with clear sampling and population criteria to facilitate the possible correlation of findings.
To the best of our knowledge, no study has explored patient experiences and outcomes post-TKA using focus-group discussions one year after surgery to explore whether there are factors that might help us to understand why some patient medical outcome measurements were good but they were not satisfied, or vice versa. Exploration of potential barriers to functional recovery may support future modifications that might improve outcomes post-TKA.
Project objectives
- To gain an in-depth understanding of experiences and perceptions of patients about outcomes post-TKA and to explore whether there are factors that might help us understand why some patients' medical outcome measurements were good but they were not satisfied, or vice versa.
- To gain insights into potential barriers to good functional recovery.
- To identify what modifications can be made to improve future outcomes post-TKA.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
Also called Total Knee Replacement surgery
surgical knee joints Arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 40 -50 minute of total 120 minute of focus group discussion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start1 Jan 2018
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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
- Other
- Time perspective
- Other
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salford
- Sponsor type
- University, hospital or other
- Collaborators
- Stockport NHS Foundation Trust
- Responsible party
- Principal investigator, Bodor Bin sheeha, University of Salford
- Investigators
- Professor Richard Professor Jones, Study director, Director of the Salford University Gait Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064334
- Sponsor's protocol ID
- qualitative
- Status last verified
- May 2018
- First submitted
- 15 Feb 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Attride-Stirling, J. (2001). Thematic networks: an analytic tool for qualitative research. Qualitative Research, 1(3), 385-405. doi:10.1177/146879410100100307
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.
PubMed 19411508Bloor, M., and Wood, F. (2006). Keywords in Qualitative Methods. A Vocabulary of Research Methods. London: SAGE Publications Ltd.
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 22398175Hossain 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.
PubMed 25568406Jagger, 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.
Kitzinger J. Qualitative research. Introducing focus groups. BMJ. 1995 Jul 29;311(7000):299-302. doi: 10.1136/bmj.311.7000.299.
PubMed 7633241Klit 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.
PubMed 24269097Lehoux 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.
PubMed 16797811Ong 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.
PubMed 16436487Palomba, C. A., & Banta, T. W. (1999). Assessment essentials : planning, implementing, and improving assessment in higher education. San Francisco: Jossey-Bass Publishers.
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.
PubMed 26224824Rastogi 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.
PubMed 17678532Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995 Apr;18(2):179-83. doi: 10.1002/nur.4770180211.
PubMed 7899572Schwandt, T. (2001). Dictionary of Qualitative Inquiry: Thousand Oaks Ca: Sage.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Views on Outcomes Following Total Knee Arthroplasty: a Focus-group Study
- ClinicalTrials.gov ID
- NCT03064334
- Acronym / sponsor ID
- qualitative
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of SalfordUniversity, hospital or other
- Collaborators
- Stockport NHS Foundation Trust
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 27 Feb 2017 (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.
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.
Detailed description
Knee osteoarthritis (OA) is a major cause of disability around the world; it is the most common chronic condition in primary care in the UK. By 2030 it is predicted to be the greatest cause of disability in the general population . An effective end-stage treatment for knee OA is knee-replacement surgery, which was first done in the 1970s and 1980s.
In England and Wales, the number of knee-replacement procedures recorded by the National Joint Registry in 2013 was 91,703, which represents an increase of 0.9 % over 2012. The data analysis by the National Joint Registry and the Office of National Statistics suggests that, by 2030, primary Total Knee Arthroplasty (TKA) will increase by 117% from the 2012 level. Subsequently, TKA revision surgeries are expected to increase incrementally by 332%. There is a similar estimation of demand for revision TKA surgeries in the United States; by 2030, they are expected to rise by 601% from the 2005 level. The United States estimation of primary TKA is for growth of 673% from the 2005 level, which is similar to England and Wales's upper-limit projections .
Post-TKA, 75-85% of patients report satisfaction with surgery outcomes, while the remaining 15-25% are dissatisfied .Total knee arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g. the presence of surgical complications or implant survival. This is gradually changing to involve the patient in measuring health outcomes and decision-making processes. Patient-reported outcome measures (PROMs) have evolved to explore patient perspectives by monitoring the quality of care in health organizations and conducting clinical trial outcomes.
More than half of patients' early concerns post-total knee arthroplasty (TKA) are not considered in commonly used patient-reported outcome measures . This may support current medical outcomes evaluation post-TKA having implications that differ from the patient perspective. This may be explained by the dissatisfaction of some patients post-TKA. So, being more sensitive to patient experience assessment methods is required, rather than profession-driven tools.
Patients' experiences and their perceptions of current outcome measurements post-TKA are poorly understood. In order to explore this area qualitative methods are appropriate, as they facilitate the collection of in-depth experiences and perceptions of 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.
A focus group is useful for exploring poorly understood areas, such as outcomes and experiences post-TKA, in order to generate possible findings or hypotheses. It has advantages over one-to-one interviews as the interaction among group members provides an extra dimension to gather data and a wider degree of spontaneity in the patient views expressed, in contrast to one-to-one interviews where the interaction is limited to that between patients and researcher and depends on patient responses. Interaction in a group setting allows patients to refine their views in light of others' views and facilitates further spontaneous expression. Support for the feelings of other group members with similar experiences encourages less verbal individuals to contribute more than in one-to-one interviews.
Only three previous studies have used focus-group methods to explore patient experiences post-TKA. Studies by Westby et al. (2010) and Van Egmond et al. (2015) combined the results of patient experiences post-total knee arthroplasty and post-total hip arthroplasty, which does not support accuracy as those patient groups encounter different problems. The third study, by Zacharia et al. (2016), assessed outcomes at least three years post-TKA in a limited age range of 60-65 years for manual labourers of low and medium socioeconomic status. An appropriate well-structured methodology is required to explore patient experiences and outcomes post-TKA, with clear sampling and population criteria to facilitate the possible correlation of findings.
To the best of our knowledge, no study has explored patient experiences and outcomes post-TKA using focus-group discussions one year after surgery to explore whether there are factors that might help us to understand why some patient medical outcome measurements were good but they were not satisfied, or vice versa. Exploration of potential barriers to functional recovery may support future modifications that might improve outcomes post-TKA.
Project objectives
- To gain an in-depth understanding of experiences and perceptions of patients about outcomes post-TKA and to explore whether there are factors that might help us understand why some patients' medical outcome measurements were good but they were not satisfied, or vice versa.
- To gain insights into potential barriers to good functional recovery.
- To identify what modifications can be made to improve future outcomes post-TKA.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one medium of focus groups | – | Procedure: Total Knee ArthroplastyThe 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Total Knee ArthroplastyAlso: Total Knee Replacement surgerysurgical knee joints Arthroplasty | Procedure or surgery | one medium of focus groups |
Primary outcome
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
1 secondary outcome
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.
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 May 2018.
- BackgroundAttride-Stirling, J. (2001). Thematic networks: an analytic tool for qualitative research. Qualitative Research, 1(3), 385-405. doi:10.1177/146879410100100307
- Background: PubMed 19411508Beaton 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.
- BackgroundBloor, M., and Wood, F. (2006). Keywords in Qualitative Methods. A Vocabulary of Research Methods. London: SAGE Publications Ltd.
- 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 25568406Hossain 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.
- BackgroundJagger, 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: PubMed 7633241Kitzinger J. Qualitative research. Introducing focus groups. BMJ. 1995 Jul 29;311(7000):299-302. doi: 10.1136/bmj.311.7000.299.
- Background: PubMed 24269097Klit 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.
- Background: PubMed 16797811Lehoux 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.
- Background: PubMed 16436487Ong 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.
- BackgroundPalomba, C. A., & Banta, T. W. (1999). Assessment essentials : planning, implementing, and improving assessment in higher education. San Francisco: Jossey-Bass Publishers.
- Background: PubMed 26224824Patel 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.
- Individual participant dataSharing planned: No
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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.
Professor Richard Professor Jones study director
Director of the Salford University Gait Laboratory
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 University of Salford 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 9 inclusion and 10 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 May 2018. 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?
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?
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.). 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 NCT03064334, which also lists 20 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 May 2018.