NCT03378986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
12 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 1, 2019

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

December 1, 2017

Last Update Submit

June 27, 2019

Conditions

Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Gait analysis

    Before surgery and 7th postoperative day

  • Change in Numeric Rating Scale

    Before surgery, 3rd and 7th postoperative day

  • Change in Timed Up and Go Test

    Before surgeryand 7th postoperative day

Study Arms (2)

Unilateral THA

Patients who underwent to unilateral total hip arthroplasty

Procedure: Unilateral total hip arthroplasty

Bilateral THA

Patients who underwent to simultaneous bilateral total hip arthroplasty

Procedure: Simultaneous bilateral total hip arthroplasty

Interventions

Unilateral total hip arthroplastyPROCEDURE

Replacement of one hip joint through a mininvasive surgical procedure

Unilateral THA
Simultaneous bilateral total hip arthroplastyPROCEDURE

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

Bilateral THA

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • from 40 to 65 years old
  • primary THA for osteoarthritis
  • ability to walk for 50 m without aids

You may not qualify if:

  • severe dysplasia (Crowe III and IV)
  • anchylosis, sub-anchylosis or surgical fusion of the coxophemoral joint
  • traumatic event
  • previous femoral and / or pelvic osteotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roberto Gatti

Rozzano, Milan, 20089, Italy

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2017

First Posted

December 20, 2017

Study Start

January 1, 2018

Primary Completion

May 31, 2018

Study Completion

July 1, 2018

Last Updated

July 1, 2019

Record last verified: 2017-12

Locations

IT(1)