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

November 14, 2018 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St. Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: THA Direct lateral
Total hip arthroplasty (THA) carried out by direct lateral approach (DLA)
Procedure: Total hip arthroplasty direct lateral approach
Other Names:
  • THA
  • Total hip replacement
EXPERIMENTAL: THA Posterior
Total hip arthroplasty (THA) carried out by posterior approach (DLA)
Procedure: Total hip arthroplasty posterior approach
Other Names:
  • THA
  • Total hip replacement
EXPERIMENTAL: THA Anterior
Total hip arthroplasty (THA) carried out by anterior approach (DLA)
Procedure: Total hip arthroplasty, anterior approach
Other Names:
  • THA
  • Total hip replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: 3 months postoperatively
Measured by 1 repetition maximum (1 RM)
3 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hip joint functionality and mobility
Time Frame: 3 months postoperatively
Measured by patient completed questionnaires and clinician reported scores
3 months postoperatively
activity level
Time Frame: 6 subsequent days postoperatively
Measured by an activity monitor
6 subsequent days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2011

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

December 9, 2011

First Submitted That Met QC Criteria

January 4, 2012

First Posted (ESTIMATE)

January 9, 2012

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 14, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Osteoarthritis

Clinical Trials on Total hip arthroplasty direct lateral approach

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe