Recovery After Total Hip Arthroplasty

Functional Recovery After Monolateral or Bilateral Total Hip Arthroplasty

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.

Study Overview

• Status: Completed
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • Milan
    • Rozzano, Milan, Italy, 20089
      • Roberto Gatti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

20 patients who undergone to unilateral THA and 20 patients who undergone to simultaneous bilateral THA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight Distribution	Ability to simmetrically load their lower limbs	Before surgery, 3rd and 7th postoperative day
Change in Centre of Pressure Length of Trace	Ability to mantain balance	Before surgery, 3rd and 7th postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait analysis	Spatio-temporal parametres of the gait and joints kinematic	Before surgery and 7th postoperative day
Change in Numeric Rating Scale	Scale for pain assessment ranging from 0 (absence of pain) to 10 (maximum pain)	Before surgery, 3rd and 7th postoperative day
Change in Timed Up and Go Test	Test for evaluating walking ability	Before surgeryand 7th postoperative day

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): July 1, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CLF17/02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No