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Completed

NCT Number: NCT03378986

Recovery After 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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Roberto Gatti

Rozzano, Milan, 20089, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unilateral total hip arthroplasty

Procedure

Replacement of one hip joint through a mininvasive surgical procedure

Simultaneous bilateral total hip arthroplasty

Procedure

Replacement of both hip joints through one-stage mininvasive surgical procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Functional Recovery After Monolateral or Bilateral Total Hip Arthroplasty

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 20, 2017
Registry last updated
Jul 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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