Survey of Running Following a TKA

NCT03848520 | Completed

• 1 other identifier: 2018-00386
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthroplasty; Knee Replacement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Total Knee Arthroplasty

Internal Registry of Patients having a TKA and with a high (\>=9) activity-scale score at anytime between preoperatively and now.

Procedure: TKA

Interventions

TKA PROCEDURE

TKA performed in the past

Total Knee Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Human adults that underwent a TKA at the investigator's Hospital and with data available on the Institution's Implants Registry

You may qualify if:

• TKA and UCLA score = or \> 9

You may not qualify if:

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

Sponsors & Collaborators

• Brigitte Jolles, MD: lead

Study Sites (1)

University Hospital of Lausanne

Lausanne, 1011, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 30 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: February 20, 2019
• Study Start: June 30, 2018
• Primary Completion: September 15, 2018
• Study Completion: July 15, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)