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Recovery After Total Hip Arthroplasty

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ClinicalTrials.gov Identifier: NCT03378986
Recruitment Status : Not yet recruiting
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Brief Summary:
This is an observational prospective study aimed to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.

Condition or disease Intervention/treatment
Total Hip Arthroplasty Procedure: Unilateral total hip arthroplasty Procedure: Simultaneous bilateral total hip arthroplasty

Detailed Description:

Introduction: Total hip arthroplasty (THA) represents a successful treatment for several hip joint pathologies. In case of bilateral hip joint involvement, the advancements in surgical techniques have made the development of bilateral THA surgery possible through one-stage procedure. This approach seems to be as safe as unilateral THA and safer than two-stage bilateral THA, but few studies considering functional outcomes in these patients without exploring outcomes linked to their motor and functional performance.

Objective: the aim of the study is to assess the lower limbs motor and functional recovery in patients who underwent to unilateral THA respect to simultaneous bilateral THA, in early postoperative phase.

Methods: 20 patients underwent to unilateral THA and 20 patients underwent to simultaneous bilateral THA will be recruited in the study. The partecipants will be aged from 40 to 65 years old, they will be undergone to primary THA for arthritis and the will be able to walk for 50 m without aids. Patients with severe dysplasia (Crowe III and IV), anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint, with traumatic event, or previous femoral and / or pelvic osteotomy, will be excluded from the study. Weight distribution and postural stability will be evaluated asking to participants to stay on two stabilometric platform with open eyes and closed eyes for 45 seconds. Gait analysis will be used to evaluate the spatio-temporal gait parametres and the ankle, knee, hip and pelvic kinematic. Pain during walking and patients' walking ability will be also evaluated throught Numeric Rating Scale (NRS) and Timed Up and Go test (TUG). Outcome measures will be collected the day before surgery, after three, seven and about forty days after surgery, except for gait analysis and Time Up and Go tests, which will not be recorded after three days.

Statistical analysis: normality and homogeneity of demographic variables and outcome measures at the baseline will be verified. Intergroup and intra-group post-intervention differences related to outcome measures will be investigated through ANOVA for repeated measurements including post hoc analysis.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Recovery After Monolateral or Bilateral Total Hip Arthroplasty
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : July 1, 2018

Group/Cohort Intervention/treatment
Unilateral THA
Patients who underwent to unilateral total hip arthroplasty
Procedure: Unilateral total hip arthroplasty
Replacement of one hip joint through a mininvasive surgical procedure

Bilateral THA
Patients who underwent to simultaneous bilateral total hip arthroplasty
Procedure: Simultaneous bilateral total hip arthroplasty
Replacement of both hip joints through one-stage mininvasive surgical procedure




Primary Outcome Measures :
  1. Change in Weight Distribution [ Time Frame: Before surgery, 3rd and 7th postoperative day ]
    Ability to simmetrically load their lower limbs

  2. Change in Centre of Pressure Length of Trace [ Time Frame: Before surgery, 3rd and 7th postoperative day ]
    Ability to mantain balance


Secondary Outcome Measures :
  1. Gait analysis [ Time Frame: Before surgery and 7th postoperative day ]
    Spatio-temporal parametres of the gait and joints kinematic

  2. Change in Numeric Rating Scale [ Time Frame: Before surgery, 3rd and 7th postoperative day ]
    Scale for pain assessment ranging from 0 (absence of pain) to 10 (maximum pain)

  3. Change in Timed Up and Go Test [ Time Frame: Before surgeryand 7th postoperative day ]
    Test for evaluating walking ability



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
20 patients who undergone to unilateral THA and 20 patients who undergone to simultaneous bilateral THA
Criteria

Inclusion Criteria:

  • from 40 to 65 years old
  • primary THA for osteoarthritis
  • ability to walk for 50 m without aids

Exclusion Criteria:

  • severe dysplasia (Crowe III and IV)
  • anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint
  • traumatic event
  • previous femoral and / or pelvic osteotomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378986


Contacts
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Contact: Roberto Gatti, Professor of Physiotherapy +39 0282245610 roberto.gatti@hunimed.eu
Contact: Federico Temporiti, Physiotherapist +39 0282246758 federico.temporiti@humanitas.it

Sponsors and Collaborators
Istituto Clinico Humanitas
  Study Documents (Full-Text)

Documents provided by Istituto Clinico Humanitas:
Study Protocol  [PDF] December 14, 2017
Statistical Analysis Plan  [PDF] December 14, 2017


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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03378986     History of Changes
Other Study ID Numbers: CLF17/02
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No