Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Sorlandet Hospital HF
Sponsor:
Information provided by (Responsible Party):
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT02028468
First received: January 3, 2014
Last updated: December 9, 2015
Last verified: December 2015
  Purpose
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 Intervention
Femoral Neck Fracture
Procedure: hemiarthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Visual Analogue Scale Pain and Patient Satisfaction [ Time Frame: Pre and postoperative, 3 and 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Timed up and go [ Time Frame: postoperative, 3 and 12 Monthes ] [ Designated as safety issue: No ]
    TUG test- Timed up and Go

  • Harris Hip Score [ Time Frame: Pre / Postoperative, 3 and 12 Months ] [ Designated as safety issue: No ]
  • Hip Osteoarthritis Disability Score [ Time Frame: Postoperative, 3 and 12 Months ] [ Designated as safety issue: No ]
  • EuroQol [ Time Frame: Postoperative, 3 and 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2014
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   70 Years to 90 Years   (Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Patients 70- 85 Years of Age -

Exclusion Criteria:

Dementia, Infection Not Suitable for Hemiarthroplasty

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028468

Contacts
Contact: terje ugland, MD 38074124 ext +47 terje.ugland@sshf.no

Locations
Norway
Sorlandet Hospital Recruiting
Kristiansand, Norway, 4604
Contact: Frode Gallefoss, Professor    +47 38073319    frode.gallefoss@sshf.no   
Principal Investigator: terje ugland, MD         
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Principal Investigator: Lars Nordsletten, Professor University of Oslo Ullevål
  More Information

Responsible Party: Sorlandet Hospital HF
ClinicalTrials.gov Identifier: NCT02028468     History of Changes
Other Study ID Numbers: 811419 
Study First Received: January 3, 2014
Last Updated: December 9, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on September 23, 2016