Hip OsteoarthritisTHA&PANCT05189964
Total Hip Arthroplasty and Physical Activity in Patients Younger Than 50 Years
An observational study of Hip Osteoarthritis and Physical Inactivity, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: THA is a widely applied procedure for osteoarthritis of the hip. After THA, one can expect an increase in physical activity due to the reduction of pain and increased range of motion of the hip joint, especially in young patients who in general have more active lifestyles. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Hip Osteoarthritis, Physical Inactivity
- How many people
- 90 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2021to 1 Oct 2024
- 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 16 to 50 years
- All sexes
- Child, Adult
Study population: Patients will be included from the patient population of the department of orthopaedics at the Radboudumc. Per year, approximately 80 patients under age of 50 years receive THA in this institute. The patient population has a male/female ratio of approximately 1:1.3, with multiple underlying diseases resulting in THA.
Who may be able to join
- The age of the patient is between 16 and 50 years.
- The patient has an indication for primary THA.
Who cannot join
- Patients with an underlying oncologic disease which results in THA.
- Patients who are not able to walk.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
About this study
Rationale: THA is a widely applied procedure for osteoarthritis of the hip. After THA, one can expect an increase in physical activity due to the reduction of pain and increased range of motion of the hip joint, especially in young patients who in general have more active lifestyles. However, these young patients and their doctors don't know which increase in physical activity can be expected.
Objective: To measure the difference in physical activity before and after THA. Study design: Longitudinal prospective single center observational study. Study population: 87 patients who have primary THA under the age of 50 years. Excluding patients with an underlying oncologic disease which results in THA.
Read more
Intervention: N.a. Main study parameters/endpoints: The first primary endpoint is physical activity in minutes per day. The other primary endpoint is MVPA in minutes per day. Secondary endpoints are difference of TUG outcomes in seconds and the difference of 6MWT outcomes in meters. For the patients experience, the COPM total scores and NRS pain scores will be measured.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study requires three outpatient clinic visits. These visits will coincide with regular outpatient clinic visits, so patients will not have to come in extra for this study. During the preoperative and 1 year postoperative visit, the patients will complete the COPM. The patient will wear a PA monitor for 7 days after each visit. Patients might experience confronting feelings while being exposed to their PA activity profile after the study or experience mild discomfort while wearing the PA monitor since it will be worn 24 hours per day for 7 days. Also, filling in the questionnaires will take some time (5-10 minutes per questionnaire series). There are no significant physical risks associated to this study.
- Conditions
- Hip Osteoarthritis, Physical Inactivity
- Medical subject headings
- Osteoarthritis, Hip, Sedentary Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from time spent active in minutes per day
Measured: preoperative, 3 months postoperative, 12 months postoperative
Change from MVPA in minutes per day
Measured: preoperative, 3 months postoperative, 12 months postoperative
Secondary outcomes (3)
TUG
Timed Up \& Go
Measured: preoperative, 3 months postoperative, 12 months postoperative
6MWT
6 minute walking test
Measured: preoperative, 3 months postoperative, 12 months postoperative
COPM
Canadian Occupational Performance Measure total scores
Measured: preoperative, 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05189964
- Sponsor's protocol ID
- THA&PA
- Acronym
- THA&PA
- Status last verified
- Dec 2021
- First submitted
- 21 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Hip Arthroplasty and Physical Activity in Patients Younger Than 50 Years
- ClinicalTrials.gov ID
- NCT05189964
- Acronym / sponsor ID
- THA&PA / THA&PA
- Conditions
- Hip Osteoarthritis, Physical Inactivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 13 Jan 2022 (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.
Rationale: THA is a widely applied procedure for osteoarthritis of the hip. After THA, one can expect an increase in physical activity due to the reduction of pain and increased range of motion of the hip joint, especially in young patients who in general have more active lifestyles. However, these young patients and their doctors don't know which increase in physical activity can be expected.
Objective: To measure the difference in physical activity before and after THA. Study design: Longitudinal prospective single center observational study. Study population: 87 patients who have primary THA under the age of 50 years. Excluding patients with an underlying oncologic disease which results in THA.
Intervention: N.a. Main study parameters/endpoints: The first primary endpoint is physical activity in minutes per day. The other primary endpoint is MVPA in minutes per day. Secondary endpoints are difference of TUG outcomes in seconds and the difference of 6MWT outcomes in meters. For the patients experience, the COPM total scores and NRS pain scores will be measured.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study requires three outpatient clinic visits. These visits will coincide with regular outpatient clinic visits, so patients will not have to come in extra for this study. During the preoperative and 1 year postoperative visit, the patients will complete the COPM. The patient will wear a PA monitor for 7 days after each visit. Patients might experience confronting feelings while being exposed to their PA activity profile after the study or experience mild discomfort while wearing the PA monitor since it will be worn 24 hours per day for 7 days. Also, filling in the questionnaires will take some time (5-10 minutes per questionnaire series). There are no significant physical risks associated to this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients will be included from the patient population of the department of orthopaedics at the Radboudumc. Per year, approximately 80 patients under age of 50 years receive THA in this institute. The patient population has a male/female ratio of approximately 1:1.3, with multiple underlying diseases resulting in THA.
Key inclusion criteria (2 listed)
- The age of the patient is between 16 and 50 years.
- The patient has an indication for primary THA.
Key exclusion criteria (2 listed)
- Patients with an underlying oncologic disease which results in THA.
- Patients who are not able to walk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from time spent active in minutes per day
Time frame: preoperative, 3 months postoperative, 12 months postoperative
Change from MVPA in minutes per day
Time frame: preoperative, 3 months postoperative, 12 months postoperative
3 secondary outcomes
TUG
Time frame: preoperative, 3 months postoperative, 12 months postoperative
6MWT
Time frame: preoperative, 3 months postoperative, 12 months postoperative
COPM
Time frame: preoperative, 12 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
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 Hip Osteoarthritis and Physical Inactivity, run by Radboud University Medical Center at 1 site in Netherlands.
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 2 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: status not confirmed, as of the sponsor's last update on 13 Jan 2022. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erim Özdemir, Bsc (6 43 808 376 ext. +31, erim.ozdemir@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from time spent active in minutes per day (time frame: preoperative, 3 months postoperative, 12 months postoperative). The study lists 2 primary outcomes in all. 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 13 Jan 2022.