Recovery After Total Hip Arthroplasty

Completed

• Conditions: Total Hip Arthroplasty
• Interventions: Procedure: Simultaneous bilateral total hip arthroplasty; Procedure: Unilateral total hip arthroplasty

• Registration Number: NCT03378986
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2017-12
• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-20
• Study Start: 2018-01-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-07-01
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bilateral THA	Simultaneous bilateral total hip arthroplasty	Patients who underwent to simultaneous bilateral total hip arthroplasty
Unilateral THA	Unilateral total hip arthroplasty	Patients who underwent to unilateral total hip arthroplasty

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Roberto Gatti; 🇮🇹 Rozzano, Milan, Italy