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Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture

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. Identifier: NCT02028468
Recruitment Status : Active, not recruiting
First Posted : January 7, 2014
Last Update Posted : September 6, 2017
Information provided by (Responsible Party):
Sorlandet Hospital HF

Brief Summary:
Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.

Condition or disease Intervention/treatment
Femoral Neck Fracture Procedure: hemiarthroplasty

Detailed Description:

The study's main objective: The purpose of the study is to test the following hypothesis. Patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by PROMs than patients operated through the lateral approach.

The study's subsidiary objectives. We aim to shed light on the following subsidiary hypotheses.

  1. A hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by DEXA around the stem, than a hemiarthroplasty inserted via a direct lateral approach.
  2. A hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by CK, than a direct lateral approach

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2014
Estimated Primary Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Anterolateral Approach
Patient Operated with Watson Jones Approach
Procedure: hemiarthroplasty
Active Comparator: Trans-gluteal Approach
Patient operated with Trans-gluteal Hardinge Approach
Procedure: hemiarthroplasty

Primary Outcome Measures :
  1. Visual Analogue Scale Pain and Patient Satisfaction [ Time Frame: Pre and postoperative, 3 and 12 Months ]

Secondary Outcome Measures :
  1. Timed up and go [ Time Frame: postoperative, 3 and 12 Monthes ]
    TUG test- Timed up and Go

  2. Harris Hip Score [ Time Frame: Pre / Postoperative, 3 and 12 Months ]
  3. Hip Osteoarthritis Disability Score [ Time Frame: Postoperative, 3 and 12 Months ]
  4. EuroQol [ Time Frame: Postoperative, 3 and 12 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years to 90 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria: Patients 70- 85 Years of Age -

Exclusion Criteria:

Dementia, Infection Not Suitable for Hemiarthroplasty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02028468

Sorlandet Hospital
Kristiansand, Norway, 4604
Sponsors and Collaborators
Sorlandet Hospital HF
Principal Investigator: Lars Nordsletten, Professor University of Oslo Ullevål

Responsible Party: Sorlandet Hospital HF Identifier: NCT02028468     History of Changes
Other Study ID Numbers: 811419
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

Keywords provided by Sorlandet Hospital HF:
Femoral Neck Fracture
Anterolateral approach
Trans-gluteal approach
Watson Jones approach
Hardinge approach

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries