Arthroplasty Clinical Trial
Official title:
Do People Run Following a TKA? A Cross-sectional Survey Study Addressed to Patients.
NCT number | NCT03848520 |
Other study ID # | 2018-00386 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 30, 2018 |
Est. completion date | July 15, 2020 |
Verified date | November 2020 |
Source | University of Lausanne Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The hypothesis of this study is that there are people running following a total knee arthroplasty (TKA). The objective is (1) to determine if there are people that ran/run following their TKA and (2), in case (1) is true, to identify some general running parameters such as duration, frequency, perceived barriers for running. Patients with a TKA and a score equal or higher than 9 on the UCLA activity scale at any time between 2 years prior to surgery and at present will be invited to participate in the trial by phone. All these patients will receive the study's information form and questionnaire by post with a pre-stamped envelope to return the documents.The survey was created and piloted internally for this study. There are 21 questions, most of them are "yes or no" and some others open questions to assess parameters such as duration of difficulties faced. The questionnaire is composed of three parts. The first part is interested in the preoperative activity (during the 2 years before surgery), the second part in the postoperative activity (during the 2 years after surgery) and the third part refers to the current practice. For each part, people are asked about specific practice parameters and modalities. Furthermore, we seek to determine whether there was/is a willingness to run following TKA, if patients receive any education/information about it and their personal attitudes towards running with a TKA. The anonymized data will be collected by the main author for subsequent analysis.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 15, 2020 |
Est. primary completion date | September 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - TKA and UCLA score = or > 9 Exclusion Criteria: - Inability to read/write in french language - Cognitive or neurological impairment |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital of Lausanne | Lausanne |
Lead Sponsor | Collaborator |
---|---|
Brigitte Jolles, MD |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in number of runners following a TKA | Due to the limited number of patients availabe the analysis will be performed through a qualitative questionnaire. It has 21 questions, most of them are "yes or no" choice and some other open to assess parameters such as "number of runners", "frequency of running" (x/week), "duration of running" (min) and "patients' attitudes towards running" (adjectives reported) with a TKA. It is a patient based questionnaire to be send to each patient and returned by post. | From preoperatively to up to 20 years following TKA. From date of the preoperative assessment until the last clinical assessment available following TKA |
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