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Hip OsteoarthritisNCT03657680

Range of Motion, Muscular Strength and Functionality of Patients Submitted to Total Hip Arthroplasty.

An observational study of Hip Osteoarthritis, run by Federal University of Health Science of Porto Alegre.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Hip Osteoarthritis
What is being tested?
Evaluation
How many people
50 participants
Where
No sites listed yet
Study dates
Jul 2015to Apr 2016
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

Official title: Description of Joint Range of Motion, Muscular Strength and Functionality of Patients Submitted to Total Hip Arthroplasty.

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.

Read the detailed description

A descriptive, comparative cross-sectional study will be conducted. Participants will attended the Physical Therapy Laboratory at the Federal University of Health Sciences of Porto Alegre in a single assessment session. This study was approved by the university's Research Ethics Committee (protocol 925.402) and, prior to data collection, all participants will read and sign a consent form.

The experimental group will be composed of a 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. Medical record information will be obtained from computerized hospital systems and potential participants will be invited by telephone to take part in the study. The control group will be composed of asymptomatic individuals from the community.

Participants will be considered eligible for the study if: they are at least 50 years old; have not undergone previous surgery and/or injection of corticosteroids to lower limb joints; have no clinical signs of osteoarthritis in other lower limbs joints; and experienced no disabling neurological or cardiovascular conditions. Individuals who have developed complications (infections, deep vein thrombosis and/or dislocation of the prosthetic component) during the postoperative period will be excluded.

Level of hip pain will be assessed using a 10-cm visual analog scale. It will be assessed in two stages: before (pre) and after completion of data collection (post-evaluation). Functional capacity will be assessed using the Timed Up and Go test and the Harris Hip Score questionnaire. To perform the Timed Up and Go test, subjects will be instructed to stand up from an armless chair and walk 3m, at their usual speed, to a mark drawn on the floor, then turn around, return to the chair and sit. The test will firstly be demonstrated by the evaluator and then performed by the participant twice, however only the second performance will be timed. Harris Hip Score is a hip joint assessment instrument; its score ranges from 0 to 100 points, consisting of pain, function, deformity and range of motion domains. The Harris Hip Score results will be classified according to the score, where: lower than 70 points is bad; between 70-79 is normal; between 80-89 is good; and, between 90-100 is excellent. Active range of motion measures will be performed in both hips by a single examiner using a fleximeter (FL6010 model, Sanny, Brazil). The protocol is adapted from the instrument manual, so that movements are assessed in the following positions: hip flexion, lying in supine and with knee flexed; hip extension, abduction and adduction, in standing position; and hip internal and external rotation, with the patient sitting on the edge of the table, with hip and knee flexed at 90º [21]. Movements will be interrupted if the second evaluator observes any compensation at the pelvis and/or trunk. The order of evaluation (affected or unaffected limb first) for fleximetry and dynamometry will be randomized using a mobile application (Randomizers - www.random.org). Hip muscles will be assessed isometrically using a BiodexTM Multi Joint System 4 Pro isokinetic dynamometer (Biodex Medical Systems, New York, USA). Equipment calibration will be performed according to the instructions in the manufacturer's manual. The chair is going to be set with 0° of inclination and the greater trochanter will be used as reference for alignment of the lower limb rotation axis. Participants' position is going to be maintained using stabilizing braces around the trunk, pelvis and contralateral limb. Patients position will took into account the postoperative limitations of THA and will be based on previous literature. Both hip flexors and extensors will be evaluated with the patient in a supine position, the tested limb in 45° of hip flexion and the contralateral limb in extension (image 1). Resistance platform will be set ~3cm above the upper limit of the patella. Both hip abductors and adductors assessments are going to be performed in side lying (image 2), the tested limb placed in 15° of hip abduction with the resistance platform lateral to the thigh, as the contralateral limb remained in flexion. Each muscle group evaluation will be preceded by an explanation of the test, as well as submaximal muscle contractions for familiarization and warm-up. Three attempts of 5s duration will be performed for each muscle group, with a 90s interval between each. Participants will be stimulated to exert their maximum strength during each attempt through verbal encouragement by the examiner.

Being tested
Evaluation
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EvaluationOther

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

Study groups in NCT03657680
Study groupRoleWhat they receive
ATQ GroupConvenience 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.
Receives: Other: Evaluation
Control GroupThe 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.
Receives: Other: Evaluation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 hour

Secondary outcomes (4)
  1. Functionality - Timed Up and Go

    Evaluation of patients functionality according to the performance in the Timed Up and Go Test. Subjects were instructed to stand up from an armless chair and walk 3m, at their usual speed, to a mark drawn on the floor, then turn around, return to the chair and sit. The test will be firstly demonstrated by the evaluator and then performed by the participant twice, however only the second performance will be timed.

    Measured: 2 minutes

  2. Functionality - Harris Hip Score

    Harris Hip Score is a hip joint assessment instrument; its score ranges from 0 to 100 points, consisting of pain, function, deformity and range of motion domains. The Harris Hip Score results were classified according to the score, where: lower than 70 points was bad; between 70-79 was normal; between 80-89 was good; and, between 90-100 was excellent. The scale evaluates pain, functionality, gait and mobility.

    Measured: 10 minutes

  3. Joint Range of Motion

    Active range of motion measures were performed in both hips by a single examiner using a phleximeter (FL6010 model, Sanny, Brazil). The protocol was adapted from the instrument manual, so that movements were assessed in the following positions: hip flexion, lying in supine and with knee flexed; hip extension, abduction and adduction, in standing position; and hip internal and external rotation, with the patient sitting on the edge of the table, with hip and knee flexed at 90º [21]. Movements were interrupted if the second evaluator observed any compensation at the pelvis and/or trunk.

    Measured: 20 minutes

  4. Pain Intensity Evaluation

    Pain in the hip joint was evaluated with a 10cm Visual Analogue Scale.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2018
  2. Study startJul 2015
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT03657680
Sponsor's protocol ID
THA patients evaluation
Status last verified
Sep 2018
First submitted
15 Aug 2018
Last updated
5 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Osteoarthritis, run by Federal University of Health Science of Porto Alegre.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Isometric Muscle Strenght - Biodex (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.

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