High Tibial Osteotomy With Allograft WedgeNCT03526172
Assessing Physical Activity Levels of Patients Following HTO.
An observational study of High Tibial Osteotomy With Allograft Wedge and High Tibial Osteotomy Without Allograft Wedge, run by University of Winchester at 1 site in United Kingdom.
Trial summary
High tibial osteotomy (HTO is often indicated in physically active patients. The insertion of a bone graft during surgery has been shown to have good clinical and biomechanical outcomes, however objective data regarding post-surgery physical activity (PA) levels in patients who have undergone HTO with and without bone… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Tibial Osteotomy With Allograft Wedge, High Tibial Osteotomy Without Allograft Wedge, Pre- and Post-operative Physical Activity Levels
- What is being tested?
- High tibial osteotomy, Allograft wedge and Accelerometer
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2019to 30 May 2020
- 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: Prospective HTO patients on a patient database at Basingstoke \& North Hampshire Hospital, UK.
Who may be able to join
- Patient undergoing unilateral medial opening wedge high tibial osteotomy at Basingstoke \& North Hampshire Hospital, UK
Who cannot join
- Concurrent procedures during HTO surgery
- The use of an off-loader knee brace in the 3 weeks leading up to surgery
- Revision surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Physical Activity Levels of Patients Following High Tibial Osteotomy (HTO) With and Without Bone Grafting.
High tibial osteotomy (HTO is often indicated in physically active patients. The insertion of a bone graft during surgery has been shown to have good clinical and biomechanical outcomes, however objective data regarding post-surgery physical activity (PA) levels in patients who have undergone HTO with and without bone grafts does not exist in the literature.
Using accelerometers and questionnaires, this study will be the first to investigate this in an objective way.
- Conditions
- High Tibial Osteotomy With Allograft Wedge, High Tibial Osteotomy Without Allograft Wedge, Pre- and Post-operative Physical Activity Levels
- Being tested
- High tibial osteotomy, Allograft wedge, Accelerometer, Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tibial osteotomyProcedure or surgery
Uni-lateral medial opening-wedge high tibial osteotomy following a minimally invasive approach.
Allograft wedgeDevice
Insertion of allograft wedge into the osteotomy gap during the HTO procedure
AccelerometerDevice
ActivPal accelerometer attached to thigh of patient to collect objective physical activity data at pre-determined intervals before and after surgery
QuestionnaireOther
Validated clinical questionnaires administered to patients to collect subjective physical activity data at pre-determined intervals before and after surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients undergoing HTO without the inclusion of any bone wedge Receives: Procedure: High tibial osteotomy; Device: Accelerometer; Other: Questionnaire | |
| Allograft | Patients undergoing HTO with the inclusion of an allograft bone wedge Receives: Procedure: High tibial osteotomy; Device: Allograft wedge; Device: Accelerometer; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective physical activity levels (measured in steps per day)
Physical activity data (step-count and body position) collected via an accelermeter that is attached to the thigh for 7 day periods at pre-determined intervals before and after surgery
Measured: 14 weeks per patient
Intensity of physical activity (measured in steps per minute)
Physical activity data (step-count and body position) collected via an accelermeter that is attached to the thigh for 7 day periods at pre-determined intervals before and after surgery
Measured: 14 weeks per patient
Secondary outcomes (2)
Subjective reasons, thoughts and feelings behind post-operative physical activity levels (thematic analysis)
interviews with fully healed patients to determine their reasons, thoughts and feelings behind their post-operative levels of physical activity
Measured: 1 hour per patient
Subjective physical activity levels
Physical activity data (step-count and body position) collected via the implementation of validated questionnaires at pre-determined intervals before and after surgery
Measured: 14 weeks per patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start26 Feb 2019
- Primary completion30 May 2020
- Study completion30 May 2020
Why it stopped: Halting of all research and elective surgeries due to the Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for High Tibial Osteotomy With Allograft WedgeStudies 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Winchester
- Sponsor type
- University, hospital or other
- Collaborators
- Hampshire Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Simon Jobson, Study director, University of Winchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526172
- Sponsor's protocol ID
- UMT057/13
- Status last verified
- Oct 2024
- First submitted
- 21 Apr 2018
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be made available to other researchers. Aggregated and analysed data will be anonymised and included in publications in peer-reviewed journals
Publications
Copeland JL, Esliger DW. Accelerometer assessment of physical activity in active, healthy older adults. J Aging Phys Act. 2009 Jan;17(1):17-30. doi: 10.1123/japa.17.1.17.
PubMed 19299836Eisenberg MH, Phillips LA, Fowler L, Moore PJ. The Impact of E-diaries and Accelerometers on Young Adults' Perceived and Objectively Assessed Physical Activity. Psychol Sport Exerc. 2017 May;30:55-63. doi: 10.1016/j.psychsport.2017.01.008. Epub 2017 Jan 31.
PubMed 28966555Falck RS, Landry GJ, Brazendale K, Liu-Ambrose T. Measuring Physical Activity in Older Adults Using MotionWatch 8 Actigraphy: How Many Days are Needed? J Aging Phys Act. 2017 Jan;25(1):51-57. doi: 10.1123/japa.2015-0256. Epub 2016 Aug 24.
PubMed 27281368Martins RC, Reichert FF, Bielemann RM, Hallal PC. One-year Stability of Objectively Measured Physical Activity in Young Brazilian Adults. J Phys Act Health. 2017 Mar;14(3):208-212. doi: 10.1123/jpah.2015-0384. Epub 2016 Dec 20.
PubMed 27997276
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Physical Activity Levels of Patients Following High Tibial Osteotomy (HTO) With and Without Bone Grafting.
- ClinicalTrials.gov ID
- NCT03526172
- Acronym / sponsor ID
- UMT057/13
- Conditions
- High Tibial Osteotomy With Allograft Wedge, High Tibial Osteotomy Without Allograft Wedge, Pre- and Post-operative Physical Activity Levels
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Halting of all research and elective surgeries due to the Covid-19 pandemic
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of WinchesterUniversity, hospital or other
- Collaborators
- Hampshire Hospitals NHS Foundation Trust
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 16 May 2018 (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.
High tibial osteotomy (HTO is often indicated in physically active patients. The insertion of a bone graft during surgery has been shown to have good clinical and biomechanical outcomes, however objective data regarding post-surgery physical activity (PA) levels in patients who have undergone HTO with and without bone grafts does not exist in the literature.
Using accelerometers and questionnaires, this study will be the first to investigate this in an objective way.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: High tibial osteotomy, Device: Accelerometer, Other: QuestionnairePatients undergoing HTO without the inclusion of any bone wedge |
| Allograft | – | Procedure: High tibial osteotomy, Device: Allograft wedge, Device: Accelerometer, Other: QuestionnairePatients undergoing HTO with the inclusion of an allograft bone wedge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective HTO patients on a patient database at Basingstoke \& North Hampshire Hospital, UK.
Key inclusion criteria (1 listed)
- Patient undergoing unilateral medial opening wedge high tibial osteotomy at Basingstoke \& North Hampshire Hospital, UK
Key exclusion criteria (3 listed)
- Concurrent procedures during HTO surgery
- The use of an off-loader knee brace in the 3 weeks leading up to surgery
- Revision surgery
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 |
|---|---|---|
| High tibial osteotomyUni-lateral medial opening-wedge high tibial osteotomy following a minimally invasive approach. | Procedure or surgery | Allograft, Control |
| Allograft wedgeInsertion of allograft wedge into the osteotomy gap during the HTO procedure | Device | Allograft |
| AccelerometerActivPal accelerometer attached to thigh of patient to collect objective physical activity data at pre-determined intervals before and after surgery | Device | Allograft, Control |
| QuestionnaireValidated clinical questionnaires administered to patients to collect subjective physical activity data at pre-determined intervals before and after surgery | Other | Allograft, Control |
Primary outcome
Objective physical activity levels (measured in steps per day)
Time frame: 14 weeks per patient
Physical activity data (step-count and body position) collected via an accelermeter that is attached to the thigh for 7 day periods at pre-determined intervals before and after surgery
Intensity of physical activity (measured in steps per minute)
Time frame: 14 weeks per patient
Physical activity data (step-count and body position) collected via an accelermeter that is attached to the thigh for 7 day periods at pre-determined intervals before and after surgery
2 secondary outcomes
Subjective reasons, thoughts and feelings behind post-operative physical activity levels (thematic analysis)
Time frame: 1 hour per patient
Subjective physical activity levels
Time frame: 14 weeks per patient
Results and safety
The study was stopped early (reason given: Halting of all research and elective surgeries due to the Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 19299836Copeland JL, Esliger DW. Accelerometer assessment of physical activity in active, healthy older adults. J Aging Phys Act. 2009 Jan;17(1):17-30. doi: 10.1123/japa.17.1.17.
- Background: PubMed 28966555Eisenberg MH, Phillips LA, Fowler L, Moore PJ. The Impact of E-diaries and Accelerometers on Young Adults' Perceived and Objectively Assessed Physical Activity. Psychol Sport Exerc. 2017 May;30:55-63. doi: 10.1016/j.psychsport.2017.01.008. Epub 2017 Jan 31.
- Background: PubMed 27281368Falck RS, Landry GJ, Brazendale K, Liu-Ambrose T. Measuring Physical Activity in Older Adults Using MotionWatch 8 Actigraphy: How Many Days are Needed? J Aging Phys Act. 2017 Jan;25(1):51-57. doi: 10.1123/japa.2015-0256. Epub 2016 Aug 24.
- Background: PubMed 27997276Martins RC, Reichert FF, Bielemann RM, Hallal PC. One-year Stability of Objectively Measured Physical Activity in Young Brazilian Adults. J Phys Act Health. 2017 Mar;14(3):208-212. doi: 10.1123/jpah.2015-0384. Epub 2016 Dec 20.
- Individual participant dataSharing planned: No. No individual participant data will be made available to other researchers. Aggregated and analysed data will be anonymised and included in publications in peer-reviewed journals
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.
Simon Jobson study director
University of Winchester
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 High Tibial Osteotomy With Allograft Wedge and High Tibial Osteotomy Without Allograft Wedge, run by University of Winchester at 1 site in United Kingdom.
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 3 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: stopped early, as of the sponsor's last update on 15 Oct 2024. 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 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 was stopped early (reason given: Halting of all research and elective surgeries due to the Covid-19 pandemic). Results are not available in the source record.
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 levels (measured in steps per day) (time frame: 14 weeks per patient). 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?
On the ClinicalTrials.gov record for NCT03526172, which also lists 4 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 15 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.