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Trial record 47 of 229 for:    strength | Norway

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01506024
Recruitment Status : Completed
First Posted : January 9, 2012
Last Update Posted : November 16, 2018
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE December 9, 2011
First Posted Date  ICMJE January 9, 2012
Last Update Posted Date November 16, 2018
Actual Study Start Date  ICMJE September 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
Muscle strength [ Time Frame: 3 months postoperatively ]
Measured by 1 repetition maximum (1 RM)
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
Abductor muscle strength [ Time Frame: 3 months postoperatively ]
Measured by 1 repetition maximum (1 RM)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
  • Hip joint functionality and mobility [ Time Frame: 3 months postoperatively ]
    Measured by patient completed questionnaires and clinician reported scores
  • activity level [ Time Frame: 6 subsequent days postoperatively ]
    Measured by an activity monitor
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results
Official Title  ICMJE Minimal Invasive Surgery in Total Hip Arthroplasty Patients; Short- and Long Term Results
Brief Summary

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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hip Osteoarthritis
Intervention  ICMJE
  • Procedure: Total hip arthroplasty direct lateral approach
    Other Names:
    • Total hip replacement
    • THA
  • Procedure: Total hip arthroplasty posterior approach
    Other Names:
    • Total hip replacement
    • THA
  • Procedure: Total hip arthroplasty, anterior approach
    Other Names:
    • Total hip replacement
    • THA
Study Arms  ICMJE
  • Active Comparator: THA Direct lateral
    Total hip arthroplasty (THA) carried out by direct lateral approach (DLA)
    Intervention: Procedure: Total hip arthroplasty direct lateral approach
  • Experimental: THA Posterior
    Total hip arthroplasty (THA) carried out by posterior approach (DLA)
    Intervention: Procedure: Total hip arthroplasty posterior approach
  • Experimental: THA Anterior
    Total hip arthroplasty (THA) carried out by anterior approach (DLA)
    Intervention: Procedure: Total hip arthroplasty, anterior approach
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01506024
Other Study ID Numbers  ICMJE 2011/450
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE St. Olavs Hospital
Investigators  ICMJE
Study Director: Lars Jacob Stovner, prof Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP