Recovery After Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

Official title:

Functional Recovery After Monolateral or Bilateral Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378986
• Other study ID #: CLF17/02
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: December 2017
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Procedure:
• Unilateral total hip arthroplasty
Replacement of one hip joint through a mininvasive surgical procedure
• Simultaneous bilateral total hip arthroplasty
Replacement of both hip joints through one-stage mininvasive surgical procedure

Locations

Country	Name	City	State
Italy	Roberto Gatti	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight Distribution	Ability to simmetrically load their lower limbs	Before surgery, 3rd and 7th postoperative day
Primary	Change in Centre of Pressure Length of Trace	Ability to mantain balance	Before surgery, 3rd and 7th postoperative day
Secondary	Gait analysis	Spatio-temporal parametres of the gait and joints kinematic	Before surgery and 7th postoperative day
Secondary	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
Secondary	Change in Timed Up and Go Test	Test for evaluating walking ability	Before surgeryand 7th postoperative day