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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04214171
Other study ID # Joao B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date February 1, 2019

Study information

Verified date September 2020
Source Faculdade de Ciências Médicas da Santa Casa de São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 1, 2019
Est. primary completion date September 1, 2017
Accepts healthy volunteers No
Gender All
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria:

- 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

- Control group without orthopaedic afections. Inclusion criteria: patients submitted to total hip arthroplasty between two years (24 months - 35 months), five years (60 months - 71 months) and 10 years (120 months - 131 months), aged between 50 and 80 years and sign the terms of free and informed consent

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Gait and muscle strength will be assessed
The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated

Locations

Country Name City State
Brazil João Barboza São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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