Assessing Physical Activity Levels of Patients Following HTO.

NCT ID: NCT03526172

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-26

Study Completion Date

2020-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

Patients undergoing HTO without the inclusion of any bone wedge

High tibial osteotomy

Intervention Type PROCEDURE

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

Accelerometer

Intervention Type DEVICE

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

Questionnaire

Intervention Type OTHER

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

Allograft

Patients undergoing HTO with the inclusion of an allograft bone wedge

High tibial osteotomy

Intervention Type PROCEDURE

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

Allograft wedge

Intervention Type DEVICE

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

Accelerometer

Intervention Type DEVICE

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

Questionnaire

Intervention Type OTHER

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

Interventions

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High tibial osteotomy

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

Intervention Type PROCEDURE

Allograft wedge

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

Intervention Type DEVICE

Accelerometer

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

Intervention Type DEVICE

Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hampshire Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Winchester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Jobson

Role: STUDY_DIRECTOR

University of Winchester

Locations

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University of Winchester

Winchester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 19299836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28966555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27281368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27997276 (View on PubMed)

Other Identifiers

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UMT057/13

Identifier Type: -

Identifier Source: org_study_id

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