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CompletedNCT03378986

Recovery After Total Hip Arthroplasty

Functional Recovery After Monolateral or Bilateral Total Hip Arthroplasty

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
Istituto Clinico Humanitas · Academic / Other
Sex
All
Age
40 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREUnilateral total hip arthroplastyReplacement of one hip joint through a mininvasive surgical procedure
PROCEDURESimultaneous bilateral total hip arthroplastyReplacement of both hip joints through one-stage mininvasive surgical procedure

Timeline

Start date
2018-01-01
Primary completion
2018-05-31
Completion
2018-07-01
First posted
2017-12-20
Last updated
2019-07-01

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03378986. Inclusion in this directory is not an endorsement.