Efficacy of Preoperative Education and Mini-invasive Surgery for Total Hip Replacement (ANRACT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Cochin Hospital
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00449228
First received: March 18, 2007
Last updated: June 4, 2012
Last verified: March 2007
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Hip
Procedure: -preoperative education and total hip replacement
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Preoperative Education and Mini-invasive Total Hip Replacement in Regard to the Attainment of Functional Independency and Reduction of Hospital Stay

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Time to reach functional independence at hospital discharge [ Time Frame: during de study ] [ Designated as safety issue: Yes ]
    Time to reach functional independence at hospital discharge


Secondary Outcome Measures:
  • Perioperative criteria : [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Perioperative criteria :

  • estimated blood loss [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    estimated blood loss

  • duration of operation [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    duration of operation

  • implant position [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    implant position

  • implant fixation [ Time Frame: during th study ] [ Designated as safety issue: Yes ]
    implant fixation

  • perioperative technical errors [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    perioperative technical errors

  • Postoperative during hospital stay: [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Postoperative during hospital stay:

  • number of patients and number of units transfused before hospital discharge [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    number of patients and number of units transfused before hospital discharge

  • total estimated blood loss [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    total estimated blood loss

  • postoperative pain [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    postoperative pain

  • skin problems [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    skin problems

  • duration of hospital stay [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    duration of hospital stay

  • Postoperative (3, 6 and 12 months): [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Postoperative (3, 6 and 12 months):

  • Harris hip score, SF-36, evaluation of satisfaction and expectation [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Harris hip score, SF-36, evaluation of satisfaction and expectation

  • Abduction strength, balance and gate [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Abduction strength, balance and gate

  • Scar assessment [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    Scar assessment

  • complications [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
    complications


Estimated Enrollment: 215
Study Start Date: April 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: -preoperative education and total hip replacement
    -preoperative education and total hip replacement
    Other Name: -preoperative education and total hip replacement
Detailed Description:

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. Preoperative education is compared to no education and the mini-invasive surgery is compared to the standard group.

The education is based on explaining to the patient what will the postoperative rehabilitation be like.

The mini-invasive THR is based on the minimisation of soft tissue trauma. It requires a specific instrumentation to allow dissection and implantation of the prosthesis. Only few studies have evaluated such a technique. However, these studies were retrospective or non-randomised and results are contradictory. Therefore, a randomised controlled clinical trial is necessary to evaluate the possible benefits and feasibility of this technique.

The primary outcome is the time to reach functional independence. Secondary outcomes evaluate the duration of hospital stay, the quality of implantation of the prosthesis, the postoperative morbidity, the functional benefits and the quality of life.

Methods: this monocentric randomised controlled clinical trial compares the preoperative education versus no preoperative education (first randomization) and the conventional THR to the mini-invasive THR (second randomization). One hundred and forty patients will be included in each group.

Expected results: preoperative education and the mini-invasive THR are prone to decrease time to functional independence, postoperative morbidity and duration of hospital stay.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449228

Contacts
Contact: Philippe ANRACT, PU-PH +33(0)1 58 41 30 98 philippe.anract@cch.ap-hop-paris.fr

Locations
France
Hopital Cochin Recruiting
Paris, France, 75014
Contact: Philippe ANRACT, PU-PH    +33(0)1 58 41 30 98    philippe.anract@cch.ap-hop-paris.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Cochin Hospital
Investigators
Principal Investigator: Philippe ANRACT, PU-PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00449228     History of Changes
Other Study ID Numbers: P051040
Study First Received: March 18, 2007
Last Updated: June 4, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Osteoarthritis,
hip replacement,
education,
randomized controlled trial,
mini-invasive surgery

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 18, 2014