Impact on Muscle Strength, Quality of Life and Functionality in Individuals Submitted to Hip Arthroplasty: a Prospective Study.

Arthroplasty Complications Clinical Trial

Official title:

Impact on Muscle Strength, Quality of Life and Functionality in Individuals Submitted to Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079479
• Other study ID #: ccazarini
• Status: Completed
• Start date: July 1, 2016
• Est. completion date: January 4, 2018

Study information

• Verified date: May 2016
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Introduction: Total hip arthroplasty has been increasingly used as a means of treating the various pathologies of this joint. However, this surgical reconstruction initially brings important deficits in subjects submitted, such as: inhibition of muscle strength, limitation of range of motion and functional deficit. Therefore, an immediate physiotherapeutic treatment is necessary in the short and long term, taking into account both biomechanical issues and the quality of life of these individuals.

Objective: To evaluate the clinical evolution of individuals submitted to total hip arthroplasty in the ten year period.

Method: Twenty individuals submitted to unilateral total hip arthroplasty will be evaluated by the medical group of hip surgeries of the Brotherhood of Santa Casa de Misericórdia of São Paulo, during a period of ten years. These individuals will undergo a primary clinical evaluation and after signing the consent form, will be evaluated functionally with the HARRIS HIP SCORE and WHOQOL-bref questionnaires and physically with the analysis of muscular strength through manual dynamometry to measure the strength level of the Muscles involved in the bilateral coxo-femoral joint, such as abductors, adductors, flexors, extensors, internal rotators, external rotators, knee joint, such as extensors and flexors, and ankle, plantar flexors. Finally, they will be referred to the kinematic gait analysis, to identify the functional characteristics of these individuals, through reflexive markers at specific anatomical points, where they will walk for 5 minutes on a treadmill at a speed of 1.5km per hour.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 4, 2018
• Est. primary completion date: December 1, 2016
• Gender: All
• Age group: 56 Years to 70 Years

Eligibility

Inclusion Criteria:

• The inclusion criteria in the study will be: patients submitted to total hip arthroplasty between 2 years (24 months - 35 months), 5 years (60 months - 71 months) and 10 years (120 months - 131 months), age between 50 and 80 years and sign the terms of free and informed consent

Exclusion Criteria:

• The exclusion criteria will be: patients with a history of prosthesis dislocations or revision of the arthroplasty, pain in the hip or lower limb region, asymmetry of the lower limbs greater than 2 centimeters, previous surgeries in the lower limbs, limitation of range of motion in the joint (Impossible to perform muscle strength tests), use of antidepressive drugs or analgesics of continuous use, chronic diseases not controlled (Hypertension, rheumatoid arthritis and diabetes) and the presence of neuromuscular pathologies

Related Conditions & MeSH terms

• Arthropathy of Hip
• Arthroplasty Complications
• Joint Diseases

Intervention

Diagnostic Test:
• Muscle Strenght assesment
Muscle Strenght assesment of the hip muscles
• 2D Kinematics Analysis
2D Kinematics Analysis of the gait

Locations

Country	Name	City	State
Brazil	Claudio Cazarini Júnior	Sao Paulo	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 (2)

Giannotti S, Bottai V, Dell'Osso G, De Paola G, Bugelli G, Guido G. The hip prosthesis in lateral femur fracture: current concepts and surgical technique. Clin Cases Miner Bone Metab. 2014 Sep;11(3):196-200. Review. — View Citation

Liu XW, Zi Y, Xiang LB, Wang Y. Total hip arthroplasty: areview of advances, advantages and limitations. Int J Clin Exp Med. 2015 Jan 15;8(1):27-36. eCollection 2015. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strenght	Hand-Held dynamometer (Lafayette)	Performed in a single evaluation