Total Hip Arthroplasty (THA)NCT06883591
Triaxial Accelerometry Study
An observational study of Total Hip Arthroplasty (THA) and Accelerometers, run by Rijnstate Hospital at 2 sites in 2 countries.
Trial summary
This study looks at how physical activity levels are in the long term after hip surgery. Arthritis can make everyday movement difficult, and hip replacement surgeries-such as total hip arthroplasty (THA) and hip resurfacing-help reduce pain and improve function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Total Hip Arthroplasty (THA), Accelerometers, Resurfacing Hip Arthroplasty
- How many people
- 32 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 22 Nov 2025to 1 Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that have previously participated in a randomised controlled trial during which they received either hip resurfacing or total hip arthroplasty.
Who may be able to join
- Patient must have participated in a previous randomised controlled trial that was conducted in Rijnstate hospital between 2007-2008.
Who cannot join
- None.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Physical Activity in Patients After Resurfacing and Total Hip Arthroplasty: an Observational Follow-up Study 15 Years After Surgery.
This study looks at how physical activity levels are in the long term after hip surgery. Arthritis can make everyday movement difficult, and hip replacement surgeries-such as total hip arthroplasty (THA) and hip resurfacing-help reduce pain and improve function. However, it is not clear how these surgeries affect long-term physical activity.
To learn more, researchers are following up with patients who had one of these surgeries 15 years ago. Participants will wear two small activity-tracking devices (accelerometers): one on their wrist for 10 days and one on their thigh for 48 hours. These devices will measure how much and how intensely they move. Participants will also complete short physical activity questionnaires.
By comparing activity levels between the two types of hip surgery, the study aims to understand their long-term effects on mobility and health. The results could help doctors improve treatment and recovery plans for future patients. All data will be kept private, and participation is voluntary.
Read the detailed description
Arthritis significantly impacts patients' quality of life, leading to pain, fatigue, and reduced mobility. Treatment strategies include medication, lifestyle changes, and surgical interventions such as total hip arthroplasty (THA) and hip resurfacing. While these procedures improve function and alleviate pain, their long-term effects on physical activity levels remain unclear. Given the importance of physical activity in maintaining health and reducing mortality risks, understanding post-surgical activity levels is crucial.
Wearable technology has revolutionized the measurement of physical activity, providing objective, large-scale data collection. This study utilizes accelerometers to evaluate physical activity in patients who underwent hip resurfacing or THA 15 years ago. By comparing these groups, researchers aim to understand the long-term impact of different surgical interventions on mobility and activity levels.
The primary objective of the study is to compare the volume and intensity of physical activity in patients who underwent hip resurfacing versus those who had a total hip replacement. We will also explore associations between physical activity levels and functional outcome scores.
This is a cross-sectional observational study involving a follow-up of patients who participated in a randomized controlled trial 15 years ago. Participants will be asked to complete questionnaires and wear two different accelerometers to monitor their physical activity. They will wear a GENEActiv triaxial accelerometer on the non-dominant wrist for 10 days and nights. They will also wear an Axivity AX3 Logging triaxial accelerometer on the surgical thigh for 48 hours. Both will measure physical activity energy expenditure (PAEE), intensity distribution of PAEE, and step count.
All participants will receive an information letter and provide informed consent before participation. Data privacy will be maintained through coded identifiers, and no personally identifiable information will be stored with the accelerometry data.
This study will provide valuable insights into the long-term mobility outcomes of patients who have undergone hip resurfacing or total hip arthroplasty. The findings will help clinicians understand the implications of surgical choices on patients' activity levels and overall health, potentially influencing future treatment recommendations and rehabilitation strategies.
- Keywords
- Total Hip Arthroplasty, Observation, Accelerometry, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resurfacing Hip Arthroplasty | Patients 15 years after hip resurfacing surgery | |
| Total Hip Arthroplasty | Patients 15 years after Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective physical activity
Physical activity energy expenditure (PAEE) and physical activity intensity distribution as measured by two accelerometers
Measured: Physical activity measured continuously for a duration of 10 days
Secondary outcomes (2)
Self-reported physical activity
Self-reported physical activity using a Dutch version of the International Physical Activity Questionnaire - Short Form (IPAQ-SF).
Measured: Seven days prior to the first day of accelerometer use
Self-reported physical activity
Self-reported physical activity using a Dutch version of the Short Questionnaire to Assess health-enhancing physical activity (SQUASH).
Measured: Seven days prior to the first day of accelerometer use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start22 Nov 2025
- Primary completion1 Apr 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Total Hip Arthroplasty (THA)Studies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
- Investigators
- Job LC Susante, MD, PhD, Principal investigator, Stichting Rijnstate Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883591
- Sponsor's protocol ID
- 2025-2605
- Other IDs
- 2025-17970, 2025
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Haverkamp D, Breugem SJ, Sierevelt IN, Blankevoort L, van Dijk CN. Translation and validation of the Dutch version of the Oxford 12-item knee questionnaire for knee arthroplasty. Acta Orthop. 2005 Jun;76(3):347-52.
PubMed 16156462Wylde V, Learmonth ID, Cavendish VJ. The Oxford hip score: the patient's perspective. Health Qual Life Outcomes. 2005 Oct 31;3:66. doi: 10.1186/1477-7525-3-66.
PubMed 16259627Dawson J, Fitzpatrick R, Murray D, Carr A. Comparison of measures to assess outcomes in total hip replacement surgery. Qual Health Care. 1996 Jun;5(2):81-8. doi: 10.1136/qshc.5.2.81.
PubMed 10158596Gosens T, Hoefnagels NH, de Vet RC, Dhert WJ, van Langelaan EJ, Bulstra SK, Geesink RG. The "Oxford Heup Score": the translation and validation of a questionnaire into Dutch to evaluate the results of total hip arthroplasty. Acta Orthop. 2005 Apr;76(2):204-11. doi: 10.1080/00016470510030580.
PubMed 16097545Stolk E, Ludwig K, Rand K, van Hout B, Ramos-Goni JM. Overview, Update, and Lessons Learned From the International EQ-5D-5L Valuation Work: Version 2 of the EQ-5D-5L Valuation Protocol. Value Health. 2019 Jan;22(1):23-30. doi: 10.1016/j.jval.2018.05.010. Epub 2019 Jan 2.
PubMed 30661630M Versteegh M, M Vermeulen K, M A A Evers S, de Wit GA, Prenger R, A Stolk E. Dutch Tariff for the Five-Level Version of EQ-5D. Value Health. 2016 Jun;19(4):343-52. doi: 10.1016/j.jval.2016.01.003. Epub 2016 Mar 30.
PubMed 27325326Devlin N, Roudijk B, Ludwig K, editors. Value Sets for EQ-5D-5L: A Compendium, Comparative Review & User Guide [Internet]. Cham (CH): Springer; 2022. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK589304/
PubMed 36810025Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
PubMed 11491192Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
PubMed 22018588Vandelanotte C, De Bourdeaudhuij I, Philippaerts R, Sjöström M, Sallis J. Reliability and Validity of a Computerized and Dutch Version of the International Physical Activity Questionnaire (IPAQ). Journal of Physical Activity and Health. 2005;2(1):63-75.
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PubMed 12900694Silsbury Z, Goldsmith R, Rushton A. Systematic review of the measurement properties of self-report physical activity questionnaires in healthy adult populations. BMJ Open. 2015 Sep 15;5(9):e008430. doi: 10.1136/bmjopen-2015-008430.
PubMed 26373402Kraus WE, Janz KF, Powell KE, Campbell WW, Jakicic JM, Troiano RP, Sprow K, Torres A, Piercy KL; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Daily Step Counts for Measuring Physical Activity Exposure and Its Relation to Health. Med Sci Sports Exerc. 2019 Jun;51(6):1206-1212. doi: 10.1249/MSS.0000000000001932.
PubMed 31095077Gerhardt DMJM, Mors TGT, Hannink G, Van Susante JLC. Resurfacing hip arthroplasty better preserves a normal gait pattern at increasing walking speeds compared to total hip arthroplasty. Acta Orthop. 2019 Jun;90(3):231-236. doi: 10.1080/17453674.2019.1594096. Epub 2019 Apr 1.
PubMed 30931667Maillot C, Auvinet E, Harman C, Cobb J, Riviere C. Hip resurfacing generates a more physiological gait than total hip replacement: A case-control study. Orthop Traumatol Surg Res. 2020 May;106(3):527-534. doi: 10.1016/j.otsr.2019.12.020. Epub 2020 Apr 4.
PubMed 32265178
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Patients After Resurfacing and Total Hip Arthroplasty: an Observational Follow-up Study 15 Years After Surgery.
- ClinicalTrials.gov ID
- NCT06883591
- Acronym / sponsor ID
- 2025-2605
- Keywords
- Total Hip Arthroplasty, Observation, Accelerometry, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 19 Mar 2025 (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.
This study looks at how physical activity levels are in the long term after hip surgery. Arthritis can make everyday movement difficult, and hip replacement surgeries-such as total hip arthroplasty (THA) and hip resurfacing-help reduce pain and improve function. However, it is not clear how these surgeries affect long-term physical activity.
To learn more, researchers are following up with patients who had one of these surgeries 15 years ago. Participants will wear two small activity-tracking devices (accelerometers): one on their wrist for 10 days and one on their thigh for 48 hours. These devices will measure how much and how intensely they move. Participants will also complete short physical activity questionnaires.
By comparing activity levels between the two types of hip surgery, the study aims to understand their long-term effects on mobility and health. The results could help doctors improve treatment and recovery plans for future patients. All data will be kept private, and participation is voluntary.
Detailed description
Arthritis significantly impacts patients' quality of life, leading to pain, fatigue, and reduced mobility. Treatment strategies include medication, lifestyle changes, and surgical interventions such as total hip arthroplasty (THA) and hip resurfacing. While these procedures improve function and alleviate pain, their long-term effects on physical activity levels remain unclear. Given the importance of physical activity in maintaining health and reducing mortality risks, understanding post-surgical activity levels is crucial.
Wearable technology has revolutionized the measurement of physical activity, providing objective, large-scale data collection. This study utilizes accelerometers to evaluate physical activity in patients who underwent hip resurfacing or THA 15 years ago. By comparing these groups, researchers aim to understand the long-term impact of different surgical interventions on mobility and activity levels.
The primary objective of the study is to compare the volume and intensity of physical activity in patients who underwent hip resurfacing versus those who had a total hip replacement. We will also explore associations between physical activity levels and functional outcome scores.
This is a cross-sectional observational study involving a follow-up of patients who participated in a randomized controlled trial 15 years ago. Participants will be asked to complete questionnaires and wear two different accelerometers to monitor their physical activity. They will wear a GENEActiv triaxial accelerometer on the non-dominant wrist for 10 days and nights. They will also wear an Axivity AX3 Logging triaxial accelerometer on the surgical thigh for 48 hours. Both will measure physical activity energy expenditure (PAEE), intensity distribution of PAEE, and step count.
All participants will receive an information letter and provide informed consent before participation. Data privacy will be maintained through coded identifiers, and no personally identifiable information will be stored with the accelerometry data.
This study will provide valuable insights into the long-term mobility outcomes of patients who have undergone hip resurfacing or total hip arthroplasty. The findings will help clinicians understand the implications of surgical choices on patients' activity levels and overall health, potentially influencing future treatment recommendations and rehabilitation strategies.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resurfacing Hip Arthroplasty | – | –Patients 15 years after hip resurfacing surgery |
| Total Hip Arthroplasty | – | –Patients 15 years after Total Hip Arthroplasty |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that have previously participated in a randomised controlled trial during which they received either hip resurfacing or total hip arthroplasty.
Key inclusion criteria (1 listed)
- Patient must have participated in a previous randomised controlled trial that was conducted in Rijnstate hospital between 2007-2008.
Key exclusion criteria (1 listed)
- None.
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
Objective physical activity
Time frame: Physical activity measured continuously for a duration of 10 days
Physical activity energy expenditure (PAEE) and physical activity intensity distribution as measured by two accelerometers
2 secondary outcomes
Self-reported physical activity
Time frame: Seven days prior to the first day of accelerometer use
Self-reported physical activity
Time frame: Seven days prior to the first day of accelerometer use
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 23 Jun 2026.
- Background: PubMed 16156462Haverkamp D, Breugem SJ, Sierevelt IN, Blankevoort L, van Dijk CN. Translation and validation of the Dutch version of the Oxford 12-item knee questionnaire for knee arthroplasty. Acta Orthop. 2005 Jun;76(3):347-52.
- Background: PubMed 16259627Wylde V, Learmonth ID, Cavendish VJ. The Oxford hip score: the patient's perspective. Health Qual Life Outcomes. 2005 Oct 31;3:66. doi: 10.1186/1477-7525-3-66.
- Background: PubMed 10158596Dawson J, Fitzpatrick R, Murray D, Carr A. Comparison of measures to assess outcomes in total hip replacement surgery. Qual Health Care. 1996 Jun;5(2):81-8. doi: 10.1136/qshc.5.2.81.
- Background: PubMed 16097545Gosens T, Hoefnagels NH, de Vet RC, Dhert WJ, van Langelaan EJ, Bulstra SK, Geesink RG. The "Oxford Heup Score": the translation and validation of a questionnaire into Dutch to evaluate the results of total hip arthroplasty. Acta Orthop. 2005 Apr;76(2):204-11. doi: 10.1080/00016470510030580.
- Background: PubMed 30661630Stolk E, Ludwig K, Rand K, van Hout B, Ramos-Goni JM. Overview, Update, and Lessons Learned From the International EQ-5D-5L Valuation Work: Version 2 of the EQ-5D-5L Valuation Protocol. Value Health. 2019 Jan;22(1):23-30. doi: 10.1016/j.jval.2018.05.010. Epub 2019 Jan 2.
- Background: PubMed 27325326M Versteegh M, M Vermeulen K, M A A Evers S, de Wit GA, Prenger R, A Stolk E. Dutch Tariff for the Five-Level Version of EQ-5D. Value Health. 2016 Jun;19(4):343-52. doi: 10.1016/j.jval.2016.01.003. Epub 2016 Mar 30.
- Background: PubMed 36810025Devlin N, Roudijk B, Ludwig K, editors. Value Sets for EQ-5D-5L: A Compendium, Comparative Review & User Guide [Internet]. Cham (CH): Springer; 2022. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK589304/
- Background: PubMed 11491192Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087.
- Background: PubMed 22018588Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
- BackgroundVandelanotte C, De Bourdeaudhuij I, Philippaerts R, Sjöström M, Sallis J. Reliability and Validity of a Computerized and Dutch Version of the International Physical Activity Questionnaire (IPAQ). Journal of Physical Activity and Health. 2005;2(1):63-75.
- Background: PubMed 12900694Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Background: PubMed 26373402Silsbury Z, Goldsmith R, Rushton A. Systematic review of the measurement properties of self-report physical activity questionnaires in healthy adult populations. BMJ Open. 2015 Sep 15;5(9):e008430. doi: 10.1136/bmjopen-2015-008430.
- 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.
Job LC Susante, MD, PhD principal investigator
Stichting Rijnstate Ziekenhuis
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Hip Arthroplasty (THA) and Accelerometers, run by Rijnstate Hospital at 2 sites in 2 countries.
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 1 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. 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?
Objective physical activity (time frame: Physical activity measured continuously for a duration of 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06883591, which also lists 43 linked publications.
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 23 Jun 2026.