ArthroplastyNCT03848520
Survey of Running Following a TKA
An observational study of Arthroplasty and Knee Replacement, run by Brigitte Jolles, MD at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Knee Replacement
- What is being tested?
- TKA
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2018to 15 Jul 2020
- How long will I take part?
- 30 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Human adults that underwent a TKA at the investigator's Hospital and with data available on the Institution's Implants Registry
Who may be able to join
- TKA and UCLA score = or > 9
Who cannot join
- Inability to read/write in french language
- Cognitive or neurological impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do People Run Following a TKA? A Cross-sectional Survey Study Addressed to Patients.
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
- Being tested
- TKA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKAProcedure or surgery
TKA performed in the past
| Study group | Role | What they receive |
|---|---|---|
| Total Knee Arthroplasty | Internal Registry of Patients having a TKA and with a high (>=9) activity-scale score at anytime between preoperatively and now. Receives: Procedure: TKA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From preoperatively to up to 20 years following TKA. From date of the preoperative assessment until the last clinical assessment available following TKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2019
- Study start30 Jun 2018
- Primary completion15 Sep 2018
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- Brigitte Jolles, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brigitte Jolles, MD, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848520
- Sponsor's protocol ID
- 2018-00386
- Other IDs
- 2018
- Status last verified
- Nov 2020
- First submitted
- 11 Jun 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do People Run Following a TKA? A Cross-sectional Survey Study Addressed to Patients.
- ClinicalTrials.gov ID
- NCT03848520
- Acronym / sponsor ID
- 2018-00386
- Conditions
- Arthroplasty, Knee Replacement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Brigitte Jolles, MDUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 15 Sep 2018 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 20 Feb 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arthroplasty | – | Procedure: TKAInternal Registry of Patients having a TKA and with a high (>=9) activity-scale score at anytime between preoperatively and now. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Human adults that underwent a TKA at the investigator's Hospital and with data available on the Institution's Implants Registry
Key inclusion criteria (1 listed)
- TKA and UCLA score = or > 9
Key exclusion criteria (2 listed)
- Inability to read/write in french language
- Cognitive or neurological impairment
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 |
|---|---|---|
| TKATKA performed in the past | Procedure or surgery | Total Knee Arthroplasty |
Primary outcome
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.
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 4 Nov 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arthroplasty and Knee Replacement, run by Brigitte Jolles, MD at 1 site in Switzerland.
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 1 inclusion and 2 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 4 Nov 2020. 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 Switzerland. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2020.