Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results

NCT ID: NCT01506024

Last Updated: 2018-11-16

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-04-30

Brief Summary

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The aim of the present study is to explore the most efficient surgical approach in total hip replacement in short and long term when concerning strength, functionality and postoperative complications.

The objective is to register muscular strength, hip joint functionality/mobilisation and complications after total hip arthroplasty (THA) performed by the direct lateral approach (DLA), the posterior approach (PA) and the anterior approach (AA). The latter is a modified Smith-Petersen approach which follows the principles of minimally invasive surgery (MIS).

The primary working hypothesis is that due to a minimal dissection and reduced trauma in the muscles, patients will tolerate early hospital discharge better after the AA than the PA and the DLA. Patients in the AA group are also thought to be more active and maintain muscular strength and hip joint functionality/mobilisation better than patients in the lateral group.

Detailed Description

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With total hip replacement surgery, the orthopaedic surgeon's aim is not only pain relief for the patient, but also restoration of hip joint biomechanics resulting in a minimal functional deficit and maximal longevity of the implant. It is not exceptional that these patients still experience mild to moderate long-term impairments postoperatively. These impairments include pain, muscle weakness of the hip abductors, contracture of the hip, gait disorders, as well as weakness of hip extensors and flexors. These problems may in turn lead to complications such as joint instability and loosening of the implant.

MIS is defined as a surgical approach performed through a short skin and muscle incision to avoid injury to muscles and tendons. Following minimally invasive approach reduced muscle trauma has been found. Moreover clinical outcome improved, as the gluteus medius muscle can be spared more successfully. However, it is debated whether or not the overall results of MIS are superior, or even as good as the traditional hip replacement surgery in terms of component placing and time to revision of the prosthesis.

Conditions

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Hip Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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THA Direct lateral

Total hip arthroplasty (THA) carried out by direct lateral approach (DLA)

Group Type ACTIVE_COMPARATOR

Total hip arthroplasty direct lateral approach

Intervention Type PROCEDURE

THA Posterior

Total hip arthroplasty (THA) carried out by posterior approach (DLA)

Group Type EXPERIMENTAL

Total hip arthroplasty posterior approach

Intervention Type PROCEDURE

THA Anterior

Total hip arthroplasty (THA) carried out by anterior approach (DLA)

Group Type EXPERIMENTAL

Total hip arthroplasty, anterior approach

Intervention Type PROCEDURE

Interventions

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Total hip arthroplasty direct lateral approach

Intervention Type PROCEDURE

Total hip arthroplasty posterior approach

Intervention Type PROCEDURE

Total hip arthroplasty, anterior approach

Intervention Type PROCEDURE

Other Intervention Names

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Total hip replacement THA Total hip replacement THA Total hip replacement THA

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for THA
* Diagnosis of primary osteoarthritis as the main cause for elective THA
* American Society of Anesthesiologists (ASA) score I, II, and stable III

Exclusion Criteria

* Musculoskeletal diseases
* Current heart/pulmonary- or malignant diseases likely to influence the physical testing performance.
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Jacob Stovner, prof

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Locations

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St. Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Winther SB, Husby VS, Foss OA, Wik TS, Svenningsen S, Engdal M, Haugan K, Husby OS. Muscular strength after total hip arthroplasty. A prospective comparison of 3 surgical approaches. Acta Orthop. 2016 Feb;87(1):22-8. doi: 10.3109/17453674.2015.1068032. Epub 2015 Aug 27.

Reference Type RESULT
PMID: 26141371 (View on PubMed)

Winther SB, Foss OA, Husby OS, Wik TS, Klaksvik J, Husby VS. Muscular strength and function after total hip arthroplasty performed with three different surgical approaches: one-year follow-up study. Hip Int. 2019 Jul;29(4):405-411. doi: 10.1177/1120700018810673. Epub 2018 Nov 13.

Reference Type RESULT
PMID: 30421633 (View on PubMed)

Other Identifiers

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2011/450

Identifier Type: -

Identifier Source: org_study_id

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