NCT00449228

Brief Summary

We propose to evaluate a preoperative education of the patient and a new surgical technique (the mini-invasive THR) that could reduce the time to achieve functional independence. The primary objective of the trial is to assess the time to reach functional independence after total hip replacement depending on the treatment groups: preoperative education versus no preoperative education and mini-invasive procedure versus standard procedure. The study hypothesis is that education and mini-invasive procedure will reduce the time to reach functional independence. This is a prospective trial with a double randomization.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
215

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

June 5, 2012

Status Verified

March 1, 2007

Enrollment Period

5.3 years

First QC Date

March 18, 2007

Last Update Submit

June 4, 2012

Conditions

Osteoarthritis of the Hip

Keywords

Osteoarthritis,hip replacement,education,randomized controlled trial,mini-invasive surgery

Outcome Measures

Primary Outcomes (1)

  • Time to reach functional independence at hospital discharge

    Time to reach functional independence at hospital discharge

    during de study

Secondary Outcomes (17)

  • Perioperative criteria :

    during the study

  • estimated blood loss

    during the study

  • duration of operation

    during the study

  • implant position

    during the study

  • implant fixation

    during th study

  • +12 more secondary outcomes

Interventions

-preoperative education and total hip replacementPROCEDURE

-preoperative education and total hip replacement

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • osteoarthritis of the hip
  • avascular necrosis of the hip
  • patient between 40 and 90 years old (included)

You may not qualify if:

  • history of previous hip operation (bone)
  • patient \>90 or \< 40
  • inflammatory arthritis
  • important proximal femur or acetabular deformity
  • complete functional independence not possible
  • BMI \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Philippe ANRACT, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe ANRACT, PU-PH

CONTACT

+33(0)1 58 41 30 98philippe.anract@cch.ap-hop-paris.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2007

First Posted

March 20, 2007

Study Start

April 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

June 5, 2012

Record last verified: 2007-03

Locations

FR(1)