NCT04928924

Brief Summary

The objective of this study is to investigate the feasibility of functional 3D biomechanical assessment and EMG analysis of gait and a sit to stand tasks in the immediate post-operative phase following total hip arthroplasty.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

June 3, 2021

Last Update Submit

June 9, 2021

Conditions

Arthritis of Hip

Keywords

Total Hip ArthroplastyTotal Hip Replacementbiomechanical assessmentgait analysismovement analysis

Outcome Measures

Primary Outcomes (1)

  • Patient adherence to study procedures

    Patients ability to attend for follow up appointments and carry out study specific biomechanical assessments

    3 months

Secondary Outcomes (9)

  • Eligible patients

    1 year

  • Recruitment rate

    1 year

  • Loss to follow up

    3 months

  • Hip angles during walking

    3 months

  • Hip loads during walking

    3 months

  • +4 more secondary outcomes

Interventions

Total Hip ArthroplastyPROCEDURE

We will be observing patients who have undergone surgical replacement of arthritic hip with an implant.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been referred to the Golden Jubilee National Hospital for total hip replacement.

You may qualify if:

  • Patients suitable for posterolateral approach total hip arthroplasty
  • Able to give informed consentAble to return to study site for follow-up
  • BMI under 35

You may not qualify if:

  • Previous hip procedure in the previous twelve months
  • Previous knee surgery other than arthroscopy and medial menisectomy in the last twelve months
  • Symptomatic foot, knee, contralateral hip or spinal pathology
  • Any medical condition limiting normal ambulation e.g. stroke, Parkinsons disease, severe lymphedema, advanced cardiac disease
  • Unable to read and understand English and follow verbal and visual instructions unless they can bring a relative or friend to all study assessments to act as a translator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, G81 4DY, United Kingdom

Location

Related Publications (19)

  • Pabinger C, Lothaller H, Portner N, Geissler A. Projections of hip arthroplasty in OECD countries up to 2050. Hip Int. 2018 Sep;28(5):498-506. doi: 10.1177/1120700018757940. Epub 2018 May 21.

    PMID: 29783896BACKGROUND

  • Lubbeke A, Katz JN, Perneger TV, Hoffmeyer P. Primary and revision hip arthroplasty: 5-year outcomes and influence of age and comorbidity. J Rheumatol. 2007 Feb;34(2):394-400. Epub 2006 Nov 15.

    PMID: 17143967BACKGROUND

  • Hossain M, Parfitt DJ, Beard DJ, Darrah C, Nolan J, Murray DW, Andrew G. Does pre-operative psychological distress affect patient satisfaction after primary total hip arthroplasty? BMC Musculoskelet Disord. 2011 Jun 1;12:122. doi: 10.1186/1471-2474-12-122.

    PMID: 21631923BACKGROUND

  • Mariconda M, Galasso O, Costa GG, Recano P, Cerbasi S. Quality of life and functionality after total hip arthroplasty: a long-term follow-up study. BMC Musculoskelet Disord. 2011 Oct 6;12:222. doi: 10.1186/1471-2474-12-222.

    PMID: 21978244BACKGROUND

  • Nilsdotter AK, Isaksson F. Patient relevant outcome 7 years after total hip replacement for OA - a prospective study. BMC Musculoskelet Disord. 2010 Mar 11;11:47. doi: 10.1186/1471-2474-11-47.

    PMID: 20222962BACKGROUND

  • Mayr E, Nogler M, Benedetti MG, Kessler O, Reinthaler A, Krismer M, Leardini A. A prospective randomized assessment of earlier functional recovery in THA patients treated by minimally invasive direct anterior approach: a gait analysis study. Clin Biomech (Bristol). 2009 Dec;24(10):812-8. doi: 10.1016/j.clinbiomech.2009.07.010. Epub 2009 Aug 21.

    PMID: 19699566BACKGROUND

  • Stief F, Schmidt A, van Drongelen S, Lenarz K, Froemel D, Tarhan T, Lutz F, Meurer A. Abnormal loading of the hip and knee joints in unilateral hip osteoarthritis persists two years after total hip replacement. J Orthop Res. 2018 Mar 14. doi: 10.1002/jor.23886. Online ahead of print.

    PMID: 29536559BACKGROUND

  • Bahl JS, Nelson MJ, Taylor M, Solomon LB, Arnold JB, Thewlis D. Biomechanical changes and recovery of gait function after total hip arthroplasty for osteoarthritis: a systematic review and meta-analysis. Osteoarthritis Cartilage. 2018 Jul;26(7):847-863. doi: 10.1016/j.joca.2018.02.897. Epub 2018 Feb 21.

    PMID: 29474993BACKGROUND

  • Kolk S, Minten MJ, van Bon GE, Rijnen WH, Geurts AC, Verdonschot N, Weerdesteyn V. Gait and gait-related activities of daily living after total hip arthroplasty: a systematic review. Clin Biomech (Bristol). 2014 Jun;29(6):705-18. doi: 10.1016/j.clinbiomech.2014.05.008. Epub 2014 Jun 2.

    PMID: 24951319BACKGROUND

  • Bennett D, Ryan P, O'Brien S, Beverland DE. Gait kinetics of total hip replacement patients-A large scale, long-term follow-up study. Gait Posture. 2017 Mar;53:173-178. doi: 10.1016/j.gaitpost.2017.01.014. Epub 2017 Jan 21.

    PMID: 28171843BACKGROUND

  • Agostini V, Ganio D, Facchin K, Cane L, Moreira Carneiro S, Knaflitz M. Gait parameters and muscle activation patterns at 3, 6 and 12 months after total hip arthroplasty. J Arthroplasty. 2014 Jun;29(6):1265-72. doi: 10.1016/j.arth.2013.12.018. Epub 2013 Dec 18.

    PMID: 24439753BACKGROUND

  • Longworth JA, Chlosta S, Foucher KC. Inter-joint coordination of kinematics and kinetics before and after total hip arthroplasty compared to asymptomatic subjects. J Biomech. 2018 Apr 27;72:180-186. doi: 10.1016/j.jbiomech.2018.03.015. Epub 2018 Mar 16.

    PMID: 29576311BACKGROUND

  • Beaulieu ML, Lamontagne M, Beaule PE. Lower limb biomechanics during gait do not return to normal following total hip arthroplasty. Gait Posture. 2010 Jun;32(2):269-73. doi: 10.1016/j.gaitpost.2010.05.007. Epub 2010 Jun 11.

    PMID: 20541940BACKGROUND

  • Lamontagne M, Beaulieu ML, Varin D, Beaule PE. Lower-limb joint mechanics after total hip arthroplasty during sitting and standing tasks. J Orthop Res. 2012 Oct;30(10):1611-7. doi: 10.1002/jor.22127. Epub 2012 Apr 16.

    PMID: 22508467BACKGROUND

  • Palan J, Manktelow A. Surgical approaches for primary total hip replacement. Orthopaedics and Trauma. 2018;32(1):1-12.

    BACKGROUND

  • Dorr LD, Maheshwari AV, Long WT, Wan Z, Sirianni LE. Early pain relief and function after posterior minimally invasive and conventional total hip arthroplasty. A prospective, randomized, blinded study. J Bone Joint Surg Am. 2007 Jun;89(6):1153-60. doi: 10.2106/JBJS.F.00940.

    PMID: 17545416BACKGROUND

  • Ewen AM, Stewart S, St Clair Gibson A, Kashyap SN, Caplan N. Post-operative gait analysis in total hip replacement patients-a review of current literature and meta-analysis. Gait Posture. 2012 May;36(1):1-6. doi: 10.1016/j.gaitpost.2011.12.024. Epub 2012 Mar 10.

    PMID: 22410129BACKGROUND

  • Bernard J, Razanabola F, Beldame J, Van Driessche S, Brunel H, Poirier T, Matsoukis J, Billuart F. Electromyographic study of hip muscles involved in total hip arthroplasty: Surprising results using the direct anterior minimally invasive approach. Orthop Traumatol Surg Res. 2018 Dec;104(8):1137-1142. doi: 10.1016/j.otsr.2018.03.013. Epub 2018 May 16.

    PMID: 29753876BACKGROUND

  • Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.

    PMID: 11018445BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Hip

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Nicholas Ohly, MBBS, FRCSEd

    Golden Jubilee National Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 16, 2021

Study Start

April 26, 2021

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)