Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH).

Completed

Conditions: Displaced femoral fracture

Registration Number: NL-OMON25934

Lead Sponsor: IHFRC

Brief Summary: Burgers PTPW, Poolman RW, Culgin S, Einhorn TA, Bhandari M, Patka P, Van Lieshout EMM, namens de HEALTH trial onderzoekers. Centrale coördinatie van een multicenter studie als alternatief voor betaling per patiënt: de ervaring bij de HEALTH-trial. Ned Tijdschr Traum 2012;20(1):2-8.<br><br> Bhandari M, Devereaux PJ, Einhorn TA, Thabane L, Schemitsch EH, Koval KJ, Frihagen F, Poolman RW, Tetsworth K, Guerra-Farfán E, Madden K, Sprague S, Guyatt G; HEALTH Investigators. Hip fracture evaluation with alternatives of total hip arthroplasty versus hemiarthroplasty (HEALTH): protocol for a multicentre randomised trial. BMJ Open. 2015 Feb 13;5(2):e006263. <br><br> Burgers PTPW, Poolman RW, Van Bakel TMJ, Tuinebreijer WE, Zielinski SM, Bhandari M, Patka P, Van Lieshout EMM, on behalf of the HEALTH and FAITH trial investigators. Reliability, Validity, and Responsiveness of the Western Ontario and McMaster Universities Osteoarthritis Index for Elderly Patients with a Femoral Neck Fracture. J Bone Joint Surg Am. 2015 May 6;97(9):751-757.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

1. Adult men or women aged 50 years and older (with no upper age limit);

2. Fracture of the femoral neck confirmed with either anteroposterior or lateral hip
radiographs, computed tomography, or magnetic resonance imaging (MRI);

Exclusion Criteria

1. Patient not suitable for arthroplasty (i.e., inflammatory arthritis, rheumatoid arthritis,
pathologic fractures, or severe osteoarthritis of the hip);

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Revision surgery within 2 years of initial surgery to promote fracture healing, relieve<br>pain, treat infection, treat a peri-prosthetic fracture, or improve function include the following:<br /><br>1. Reduction of hip dislocation;<br /><br>2. Revision surgery with another implant;<br /><br>3. Incision and drainage for any infection;<br /><br>4. Implant exchange or removal.

Secondary Outcome Measures

Name	Time	Method
1. Functional outcome score (WOMAC);<br /><br>2. Functional mobility score (TUG);<br /><br>3. Quality of life (SF-12, EQ-5D);<br /><br>4. Cost-utility ratio (using Health-care consumption questionnaire);<br /><br>5. Complication rate, including mortality, implant breakage or failure, peri-prosthetic fracture, and infection (i.e., superficial and deep).