NCT03657680

Brief Summary

Subjects in the late postoperative phase (5-8 months) of THA and control subjects without any signs or symptoms in the hip joint will be assessed for functionality (Harris Hip Score questionnaire and Timed Up and Go test), level of pain (visual analogue pain scale), hip range of motion and muscle isometric peak torque. This evaluation will be performed in order to compare functionality, level of pain, hip range of motion and peak torque between patients following total hip arthroplasty (THA) and asymptomatic controls.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

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

July 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

August 15, 2018

Last Update Submit

September 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Isometric Muscle Strenght - Biodex

    Hip muscle isometric strenght were assessed isometrically using a BiodexTM Multi Joint System 4 Pro isokinetic dynamometer (Biodex Medical Systems, New York, USA). Flexor, extensor, abductor and adductor muscle strength were measured.

    1 hour

Secondary Outcomes (4)

  • Functionality - Timed Up and Go

    2 minutes

  • Functionality - Harris Hip Score

    10 minutes

  • Joint Range of Motion

    20 minutes

  • Pain Intensity Evaluation

    5 minutes

Study Arms (2)

ATQ Group

Convenience sample of patients from Porto Alegre (RS, Brazil) who were experiencing unilateral hip osteoarthritis and were submitted to THA in referral hospitals at least five months previously to data collection. The volunteers were submitted to an evaluation of pain, range of motion, muscular strength and functional capacity.

Other: Evaluation

Control Group

The control group was composed of asymptomatic individuals from the community. The volunteers were submitted to an evaluation of pain, range of motion, muscular strength and functional capacity.

Other: Evaluation

Interventions

The volunteers were submitted to an evaluation of pain, range of motion, muscular strength and functional capacity.

ATQ GroupControl Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients submited to unilateral total hip arthroplasty and healthy subjects, with no signs and symptons envolving hip joint.

You may qualify if:

  • Age equal or superior to 50 years;
  • have undergone a surgical procedure of unilateral total hip arthroplasty (cemented, non-cemented and hybrid prostheses) for at least 5 months and at most 18 months;
  • referred by orthopedic physicians in the city of Porto Alegre or whose information (date of surgery, telephone contact, age and sex) were obtained through access to the computerized system in the physiotherapy sector of reference hospitals;
  • who read and consent to the Informed Consent Form and understood the orientations necessary for the evaluation proposed in this study.

You may not qualify if:

  • Performing a surgical procedure on other joints in the lower limbs;
  • previous surgical procedures in the hip joint; osteoarticular diseases in lower limb joints;
  • presence of signs or symptoms of contralateral hip osteoarthrosis;
  • performed intra-articular injection of corticosteroids in the lower limbs during the last six months;
  • cardiovascular diseases with the presence of disability, such as severe dyspnea and uncontrolled arterial hypertension;
  • history of labyrinthitis;
  • diabetes mellitus with signs of peripheral neuropathy and the presence of neurological diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Bruna M Lopes, Prof

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

August 15, 2018

First Posted

September 5, 2018

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share