Skip to main content
Clinical Trials/NCT03378986
NCT03378986
Completed
Not Applicable

Functional Recovery After Monolateral or Bilateral Total Hip Arthroplasty

Istituto Clinico Humanitas1 site in 1 country40 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Hip Arthroplasty
Sponsor
Istituto Clinico Humanitas
Enrollment
40
Locations
1
Primary Endpoint
Change in Centre of Pressure Length of Trace
Status
Completed
Last Updated
6 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
July 1, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istituto Clinico Humanitas
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Change in Centre of Pressure Length of Trace

Time Frame: Before surgery, 3rd and 7th postoperative day

Ability to mantain balance

Change in Weight Distribution

Time Frame: Before surgery, 3rd and 7th postoperative day

Ability to simmetrically load their lower limbs

Secondary Outcomes

  • Gait analysis(Before surgery and 7th postoperative day)
  • Change in Numeric Rating Scale(Before surgery, 3rd and 7th postoperative day)
  • Change in Timed Up and Go Test(Before surgeryand 7th postoperative day)

Study Sites (1)

Loading locations...

Similar Trials