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OpenTrials
Completed

NCT Number: NCT03848520

Survey of Running Following a TKA

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Lausanne

Lausanne, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • TKA and UCLA score = or > 9

Exclusion criteria

  • Inability to read/write in french language
  • Cognitive or neurological impairment

Treatment and study plan

TKA

Procedure

TKA performed in the past

Primary outcomes

  1. Changes in number of runners following a TKA

    Time frame: From preoperatively to up to 20 years following TKA. From date of the preoperative assessment until the last clinical assessment available following 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.

Sponsors and collaborators

Lead sponsor

Brigitte Jolles, MD

Other

Registry information

Official study title

Do People Run Following a TKA? A Cross-sectional Survey Study Addressed to Patients.

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Feb 20, 2019
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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