Assessing Physical Activity Levels of Patients Following HTO.

NCT03526172 | Terminated

• 1 other identifier: UMT057/13
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

High Tibial Osteotomy With Allograft Wedge; High Tibial Osteotomy Without Allograft Wedge; Pre- and Post-operative Physical Activity Levels

Outcome Measures

Primary Outcomes (2)

• 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

  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

  14 weeks per patient

Secondary Outcomes (2)

• Subjective reasons, thoughts and feelings behind post-operative physical activity levels (thematic analysis)

  1 hour per patient

• Subjective physical activity levels

  14 weeks per patient

Study Arms (2)

Control

Patients undergoing HTO without the inclusion of any bone wedge

Procedure: High tibial osteotomy; Device: Accelerometer; Other: Questionnaire

Allograft

Patients undergoing HTO with the inclusion of an allograft bone wedge

Procedure: High tibial osteotomy; Device: Allograft wedge; Device: Accelerometer; Other: Questionnaire

Interventions

High tibial osteotomy PROCEDURE

Uni-lateral medial opening-wedge high tibial osteotomy following a minimally invasive approach.

Allograft; Control

Allograft wedge DEVICE

Insertion of allograft wedge into the osteotomy gap during the HTO procedure

Allograft

Accelerometer DEVICE

ActivPal accelerometer attached to thigh of patient to collect objective physical activity data at pre-determined intervals before and after surgery

Allograft; Control

Questionnaire OTHER

Validated clinical questionnaires administered to patients to collect subjective physical activity data at pre-determined intervals before and after surgery

Allograft; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prospective HTO patients on a patient database at Basingstoke \& North Hampshire Hospital, UK.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Winchester: lead
• Hampshire Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

University of Winchester

Winchester, SO22 4NR, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 19299836 BACKGROUND

• 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.

  PMID: 28966555 BACKGROUND

• 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.

  PMID: 27281368 BACKGROUND

• 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.

  PMID: 27997276 BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Simon Jobson

  University of Winchester

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: May 16, 2018
• Study Start: February 26, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)