NCT04214171

Brief Summary

Introduction: Femoral and acetabular replacement is characterized as total hip arthroplasty (THA). It has been used as treatment of various pathologies of this joint. In the postoperative period, some studies have shown that strength, function, range of motion and lower limb mechanics remains altered for more than One year after THA in relation to the non-operated side. However, studies that have correlated kinematics and hip muscle strength in individuals who underwent THA for long time, do not exist in literature. Objective: to evaluate lower limb muscle strength and 2D kinematics during stair ascending and descending in patients undergoing total hip arthroplasty. Methods: Third individuals who underwent total hip arthroplasty (THA) will be recruited at two, five and 10 year postoperative periods. They were allocated in three groups: Group 1 (10n), subjects submitted to THA for two years, Group 2 (10n) subjects submitted to THA for five years, Group 3 (10n) subjects submitted to THA for 10 years and Group 4 (10n) subjects without orthopaedic afections, all will be evaluated for dynamometric isometric muscle strength and kinematic analysis of stair ascending and descending by a "blinded" physical Therapist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

January 3, 2018

Last Update Submit

September 4, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • kinematic analysis of hip movements for flexion

    Analysis of the movements of the hip - range of motion for flexion

    evaluated at 10 years after hip arthroplasty

  • kinematic analysis of hip movements for extension

    Analysis of the movements of the hip - range of motion for extension

    evaluated at 10 years after hip arthroplasty

  • kinematic analysis of hip movements for internal rotation

    Analysis of the movements of the hip - range of motion for internal rotation

    evaluated at 10 years after hip arthroplasty

  • kinematic analysis of hip movements external rotation

    Analysis of the movements of the hip - range of motion for external rotation

    evaluated at 10 years after hip arthroplasty

Study Arms (4)

group 2 years

The group underwent total hip arthroplasty at 2 years

Diagnostic Test: Gait and muscle strength will be assessed

group 5 years

The group underwent total hip arthroplasty at 5 years

Diagnostic Test: Gait and muscle strength will be assessed

group 10 years

The group underwent total hip arthroplasty at 10 years

Diagnostic Test: Gait and muscle strength will be assessed

group control

healthy patients

Diagnostic Test: Gait and muscle strength will be assessed

Interventions

The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated

group 10 yearsgroup 2 yearsgroup 5 yearsgroup control

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group

You may qualify if:

  • The investigators will recruit 40 individuals who underwent total hip arthroplasty (THA) by the hospital hip surgery group in the periods of two, five and 10 years postoperatively

You may not qualify if:

  • patients with a history of prosthesis dislocations or revision of arthroplasty
  • hip or lower limb pain
  • asymmetry of the lower limbs greater than two centimeters
  • previous surgeries in the lower limbs
  • limited range of motion in the hip joint
  • use of antidepressive drugs or analgesics for continuous use
  • Presence of neuromuscular pathologies and functional incapacity to perform the activities proposed in the Kinematics analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

João Barboza

São Paulo, 04660000, Brazil

Location

Related Publications (1)

  • Foucher KC, Cinnamon CC, Ryan CA, Chmell SJ, Dapiton K. Hip abductor strength and fatigue are associated with activity levels more than 1 year after total hip replacement. J Orthop Res. 2018 May;36(5):1519-1525. doi: 10.1002/jor.23783. Epub 2017 Nov 28.

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Gait

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Vera Lucia Santos Alves, Dr

    Faculdade de Ciências Médicas da Santa Casa de São Paulo

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physical Therapy and Professor

Study Record Dates

First Submitted

January 3, 2018

First Posted

January 2, 2020

Study Start

January 1, 2017

Primary Completion

September 1, 2017

Study Completion

February 1, 2019

Last Updated

September 9, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations