Clinical trial NCT03526172: Assessing Physical Activity Levels of Patients Following HTO.
Official title: Assessing Physical Activity Levels of Patients Following High Tibial Osteotomy (HTO) With and Without Bone Grafting.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: High Tibial Osteotomy With Allograft Wedge
High Tibial Osteotomy Without Allograft Wedge
Pre- and Post-operative Physical Activity Levels
Lead sponsor: University of Winchester
Sponsor class: OTHER
Collaborators: name: Hampshire Hospitals NHS Foundation Trust
First posted: 2018-05-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective HTO patients on a patient database at Basingstoke \& North Hampshire Hospital, UK.

Brief 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 grafts does not exist in the literature.

Using accelerometers and questionnaires, this study will be the first to investigate this in an objective way.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing unilateral medial opening wedge high tibial osteotomy at Basingstoke \& North Hampshire Hospital, UK

Exclusion Criteria:

* Concurrent procedures during HTO surgery
* The use of an off-loader knee brace in the 3 weeks leading up to surgery
* Revision surgery

Primary outcomes:
measure: Objective physical activity levels (measured in steps per day)
timeFrame: 14 weeks per patient
measure: Intensity of physical activity (measured in steps per minute)
timeFrame: 14 weeks per patient
Secondary outcomes:
measure: Subjective reasons, thoughts and feelings behind post-operative physical activity levels (thematic analysis)
timeFrame: 1 hour per patient
measure: Subjective physical activity levels
timeFrame: 14 weeks per patient
Other outcomes:
Locations:
city: Winchester
country: United Kingdom
facility: University of Winchester
Study officials:
affiliation: University of Winchester
name: Simon Jobson
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Eisenberg 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.
citation: Falck 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.
citation: Martins 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.