Comparison of Direct Anterior and Posterior Surgical Approaches in Regards to the Patient' Physical Characteristics

NCT ID: NCT03472755

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-23

Study Completion Date

2020-01-20

Brief Summary

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Recent increased interest in tissue-sparing and minimally invasive arthroplasty has given rise to a sharp increase in the utilization of direct anterior total hip arthroplasty.

Detailed Description

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* Purpose: The direct anterior approach to the hip has been suggested to have several advantages compared to previously classical approaches. However, no studies focused on the effects of these different surgeries on patients' perception recovery and walking efficiency according the initial physical fitness. Therefore, the purpose of this study is to compare the effects of surgical procedures on perceptual walking skills and efficiency according to the patients' physical fitness.
* Abstract : Some earlier studies report differences between surgery types in self- reported mobility, functional recovery and residual hip pain. The direct anterior approach to the hip has been suggested to have several advantages compared to previously popular approaches through its use of an intra-muscular and intra-nervous interval between the tensor fasciae latae and sartorius muscles. However, patients' physical fitness, postural response and perceptual walking skill relation was not taking account. 80 patients will be tested, one before and at various times after hip surgery. In randomized conditions, our patients will be divided in two groups, according the surgery approaches and their physical fitness. All patients performed a Performance-Oriented Mobility Assessment Walking test with and without step and the PMA, Harris, Oxford 12 and Womac scores will be evaluated before, 3 weeks, 6 weeks, 3 months and 1 year after the surgery. During the Performance-Oriented Mobility Assessment Walking test, self-reported walking capacity, rating of exertion perception and walking parameters will be measured.

Conditions

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Hip Arthropathy

Keywords

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hip arthroplasty surgeries physical fitness perception energetic cost autonomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients provided written informed consent to participate in this study, as approved by the local ethics committee. Prior to surgery, patients were informed about the benefits and risk of the conventional posterolateral and direct anterior approaches. Then they performed postural test and a Performance-Oriented Mobility Assessment Walking test with and without step. After randomization, patients were operated according the conventional posterolateral or direct anterior techniques.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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The posterolateral approach

The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone

Group Type OTHER

The posterolateral approach

Intervention Type OTHER

The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone

Direct anterior techniques.

. In the direct anterior technique, patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached.

Group Type OTHER

Direct anterior technique

Intervention Type OTHER

patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached

Interventions

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The posterolateral approach

The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone

Intervention Type OTHER

Direct anterior technique

patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 50 years
* Body mass index \< 35
* Scheduled hip arthroplasty surgery

Exclusion Criteria

* No health coverage
* Age \> 85 years
* Body mass index ≥ 35
* Cognitive impairment (score Mini Mental Statue \< 24)
* Any other osteo-articular diseases than the operated hip, any muscular or neurological diseases that could penalize the walk
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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PI2017_843_0023

Identifier Type: -

Identifier Source: org_study_id