Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty (APAF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sundsvall Hospital
ClinicalTrials.gov Identifier:
NCT01486641
First received: December 2, 2011
Last updated: October 23, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to determine whether the anterolateral in comparison to posterolateral approach to the hip arthroplasty gives an equal or better clinical results.


Condition Intervention
Femoral Neck Fracture
Procedure: Anterolateral approach

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty - a Change in Approach at Sundsvall Hospital.

Resource links provided by NLM:


Further study details as provided by Sundsvall Hospital:

Primary Outcome Measures:
  • Womac [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EQ5D [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]
  • Harris Hip Score [ Time Frame: 1 year postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: February 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anterolateral approach

Patients with a displaced femoral neck fracture operated through the anterolateral approach to the hip arthroplasty.

Lubinus total hip arthroplasty or varikopf hemiarthroplasty.

Procedure: Anterolateral approach
Anterolateral approach acording to Gammer for hip arthroplasty.
Other Names:
  • Anterolateral approach according to Gammer.
  • Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
No Intervention: Posterolateral approach

Patients with a displaced femoral neck fracture operated through the posterolateral approach to the hip arthroplasty.

Lubinus total hip arthroplasty or varikopf hemiarthroplasty.


Detailed Description:

The purpose of this study is to compare the anterolateral- to posterolateral approaches in patients suffering a displaced femoral neck fracture operated with an hip arthroplasty. Our hypothesis is that the anterolateral approach gives equal or better clinical function, health related quality of life and less complication and reoperations.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 65 years
  • Displaced femoral neck fracture (Garden 3-4)
  • Independent walker with or without help

Exclusion Criteria:

  • Pathologic fracture
  • Not independent walker
  • Contradiction to arthroplasty by other condition (opened wound, ASA > 4, severe blood clotting deficiency).
  • Not Swedish speaker
  • Not living in Västernorrlands county
  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: NCT01486641

Locations
Sweden
Sundsvall Hospital
Sundsvall, Västernorrlands län, Sweden, 851 86
Sponsors and Collaborators
Sundsvall Hospital
  More Information

Publications:
Responsible Party: Sundsvall Hospital
ClinicalTrials.gov Identifier: NCT01486641     History of Changes
Other Study ID Numbers: Sebastian-12
Study First Received: December 2, 2011
Last Updated: October 23, 2014
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Sundsvall Hospital:
femoral neck fracture
arthroplasty
surgical approach
anterolateral
posterolateral

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

ClinicalTrials.gov processed this record on November 24, 2014