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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2020
Source University of Lausanne Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
TKA
TKA performed in the past

Locations

Country Name City State
Switzerland University Hospital of Lausanne Lausanne

Sponsors (1)

Lead Sponsor Collaborator
Brigitte Jolles, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

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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