Comparing the Clinical Effects of Posterior Approach Versus Lateral Approach in Osteoarthritis Patients With a THA

NCT01616667 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-06-04

No results posted yet for this study

Summary

The aim of this study is to investigate the clinical outcome of the two different, but widely used, surgical approaches (Posterior approach and Lateral approach) of primary total hip arthroplasty in patients diagnosed with osteoarthritis. This study is divided into one main study and two sub-studies. The main study investigates the patient-reported outcome measures (questionnaire) within the first year post surgery. The two sub-studies investigate; i) the level of physical function and pain within the first 3 month after surgery, and ii) investigate the potential difference the two approaches have on gait-patterns and maximal isometric hip-muscle-strength, within the first year after surgery. Both approaches are described with potential drawbacks. Posterior approach has a higher risk of dislocation of the prostheses and revision due to dislocation compared with Lateral approach. Contrary, Lateral approach is described with the potential drawbacks of pain, lower physical function, gait abnormalities and muscle weakness, leading to less satisfied patients. However, according to a Cochrane analysis from 2004 concludes, more investigation is needed to determine the extent of differences.

Conditions

  • Unilateral Primary Osteoarthritis of Hip

Interventions

PROCEDURE

Total hip arthroplasty

The patients included is operated with a total hip arthroplasty due to primary osteoarthritis

Sponsors & Collaborators

  • Orthopaedic department of Køge Hospital

    collaborator UNKNOWN
  • Region Zealand

    collaborator OTHER
  • Region of Southern Denmark

    collaborator OTHER
  • University of Southern Denmark

    collaborator OTHER
  • The Danish Rheumatism Association

    collaborator OTHER
  • Bevica Fonden

    collaborator OTHER
  • Bjarne Jensens Fond

    collaborator UNKNOWN
  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Signe Rosenlund, MD · Odense University Hospital and University of Southern Denmark

  • Søren Overgaard, MD, Professor · Odense University Hospital and University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01616667 on ClinicalTrials.gov