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

Osteoarthritis of the Hip Clinical Trial

— ANRACT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00449228
• Other study ID #: P051040
• Status: Recruiting
• Phase: Phase 3
• First received: March 18, 2007
• Last updated: June 4, 2012
• Start date: April 2007
• Est. completion date: July 2012

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Philippe ANRACT, PU-PH
• Phone: +33(0)1 58 41 30 98
• Email: philippe.anract[@]cch.ap-hop-paris.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 215
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Hip
• Osteoarthritis, Hip

Intervention

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

Locations

Country	Name	City	State
France	Hopital Cochin	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Cochin Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to reach functional independence at hospital discharge	Time to reach functional independence at hospital discharge	during de study	Yes
Secondary	Perioperative criteria :	Perioperative criteria :	during the study	Yes
Secondary	estimated blood loss	estimated blood loss	during the study	Yes
Secondary	duration of operation	duration of operation	during the study	Yes
Secondary	implant position	implant position	during the study	Yes
Secondary	implant fixation	implant fixation	during th study	Yes
Secondary	perioperative technical errors	perioperative technical errors	during the study	Yes
Secondary	Postoperative during hospital stay:	Postoperative during hospital stay:	during the study	Yes
Secondary	number of patients and number of units transfused before hospital discharge	number of patients and number of units transfused before hospital discharge	during the study	Yes
Secondary	total estimated blood loss	total estimated blood loss	during the study	Yes
Secondary	postoperative pain	postoperative pain	during the study	Yes
Secondary	skin problems	skin problems	during the study	Yes
Secondary	duration of hospital stay	duration of hospital stay	during the study	Yes
Secondary	Postoperative (3, 6 and 12 months):	Postoperative (3, 6 and 12 months):	during the study	Yes
Secondary	Harris hip score, SF-36, evaluation of satisfaction and expectation	Harris hip score, SF-36, evaluation of satisfaction and expectation	during the study	Yes
Secondary	Abduction strength, balance and gate	Abduction strength, balance and gate	during the study	Yes
Secondary	Scar assessment	Scar assessment	during the study	Yes
Secondary	complications	complications	during the study	Yes