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

Study Description

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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.

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

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	215 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (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
Study Start Date :	April 2007
Estimated Primary Completion Date :	July 2012
Estimated Study Completion Date :	July 2012

Arms and Interventions

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Intervention Details:

Procedure: -preoperative education and total hip replacement
-preoperative education and total hip replacement

Outcome Measures

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Primary Outcome Measures :

1. Time to reach functional independence at hospital discharge [ Time Frame: during de study ]
   Time to reach functional independence at hospital discharge

Secondary Outcome Measures :

1. Perioperative criteria : [ Time Frame: during the study ]
   Perioperative criteria :
2. estimated blood loss [ Time Frame: during the study ]
   estimated blood loss
3. duration of operation [ Time Frame: during the study ]
   duration of operation
4. implant position [ Time Frame: during the study ]
   implant position
5. implant fixation [ Time Frame: during th study ]
   implant fixation
6. perioperative technical errors [ Time Frame: during the study ]
   perioperative technical errors
7. Postoperative during hospital stay: [ Time Frame: during the study ]
   Postoperative during hospital stay:
8. number of patients and number of units transfused before hospital discharge [ Time Frame: during the study ]
   number of patients and number of units transfused before hospital discharge
9. total estimated blood loss [ Time Frame: during the study ]
   total estimated blood loss
10. postoperative pain [ Time Frame: during the study ]
    postoperative pain
11. skin problems [ Time Frame: during the study ]
    skin problems
12. duration of hospital stay [ Time Frame: during the study ]
    duration of hospital stay
13. Postoperative (3, 6 and 12 months): [ Time Frame: during the study ]
    Postoperative (3, 6 and 12 months):
14. Harris hip score, SF-36, evaluation of satisfaction and expectation [ Time Frame: during the study ]
    Harris hip score, SF-36, evaluation of satisfaction and expectation
15. Abduction strength, balance and gate [ Time Frame: during the study ]
    Abduction strength, balance and gate
16. Scar assessment [ Time Frame: during the study ]
    Scar assessment
17. complications [ Time Frame: during the study ]
    complications

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, India

Investigators

Principal Investigator:	Philippe ANRACT, PU-PH	Assistance Publique - Hôpitaux de Paris

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00449228 History of Changes
Other Study ID Numbers:	P051040
First Posted:	March 20, 2007
Last Update Posted:	June 5, 2012
Last Verified:	March 2007

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