Cemented Versus Uncemented Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures
Condition: Femoral Neck Fractures
MeSH terms: Fractures, Bone; Femoral Neck Fractures
Study type: Interventional

Summary: 
      The purpose of this prospective randomized study is to compare the quality of treatment
      between cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip
      Arthroplasty (THA) in patients who suffers from dislocated femoral neck fractures.

      Our hypothesis is that an uncemented option spares the patient the operative load of the
      cementing procedure, i e risk of fatty embolism and inflammatory response, which in turn also
      perhaps reduces the postoperative cognition strain and improves mobilization parameters.

      If the uncemented option has the same excellent fixation in poor bone stock, as in the case
      of these osteopenic fractures, and also has the same good clinical outcome, it would be a
      viable standard option for the treatment of dislocated femoral neck fractures.
    

Detailed description: 
      Corail-SP study. A prospective randomized study to compare the quality of treatment between
      cemented versus uncemented hydroxyapatite coated femoral stems in Total Hip Arthroplasty
      (THA) in patients who suffers from dislocated femoral neck fractures.

      Femoral neck fractures often occurs among the fragile elderly patients who have a higher
      degree of co-morbidity. The 3-month mortality is 13%. The incidence of risk of fracture
      complications when using osteosyntheses are as high as 30-40%, mainly due to non union, which
      leads to impairments in quality of life, locomotion and pain.

      For that reason more patients nowadays are submitted to a cemented hemiarthroplasty or a
      total hip arthroplasty directly after their injury - at the same time the problem with fatty
      embolism syndrome has been recognized. When cementing during surgery, the bone marrow is
      pushed into the blood stream, which can affect the cardiopulmonary function and even the
      mental functions.

      As a measure for reducing those risks an uncemented hip arthroplasty is sometimes used
      instead.

      The pros and cons with uncemented fixation is poorly examined which this study will try to
      scrutinize.

      100 patients with dislocated (Garden classification III-IV) femoral neck fractures who have
      the clinical indication of undergoing a Total Hip Arthroplasty are asked and included at
      Mölndals Hospital (part of Sahlgrenska University Hospital).

      Randomization to either; an inversed hybrid arthroplasty with an uncemented hydroxyapatite
      coated Corail stem and a cemented Marathon cup (DePuy), alternatively to, a totally cemented
      option with a Lubinus SPII stem and a IP cup (Link).

      Preoperatively:

      Patient questionnaires regarding cognitive and social status, hip function, quality of life
      (QoL), activity level. Standard hip and pelvis X-ray. Blood sample for biomarkers.

      Peroperatively:

      Pulmonary artery catheter measurements of pulmonary artery pressure, cardiac output, ejection
      fraction of the right ventricle. Surgeon's questionnaire regarding prosthesis components,
      duration of surgery, blood group, bleeding volume, oxygen saturation. Half of the patients
      are marked with tantalum pellets for radiostereometric analysis (RSA). Biomarkers.

      Postoperatively:

      Standard X-ray. On the patients marked with tantalum pellets RSA is performed. Bone density
      scan (DXA). Measurements regarding cognition, ADL, mobilization. Eventual confusion is noted.
      Biomarkers every second day until discharge from hospital. Eventual wound infections or
      thromboembolic episodes are noted.

      Follow up:

      Outpatient return visits to physician 3, 6 months, 1, 2, 5, 7, 10 years postoperatively.
      Standard X-ray, RSA, DXA, Patient questionnaires regarding patient's satisfaction, QoL,
      activity level, hip function. Biomarkers.

      Eventual gains with an uncemented prosthesis:

      Reduced fatty embolism risk, reduced inflammatory response, reduced generalized
      symptoms/confusion, faster mobilization, shorter surgery.
    

Intervention name(s): Total Hip Arthroplasty; Cemented Lubinus SPII stem (control arm); Uncemented HA Coated Corail stem
Intervention type(s): Procedure; Device; Device
Intervention description(s): Cemented Lubinus femoral stem. Cemented IP acetabular cup. (Link).; Uncemented hydroxyapatite coated Corail femoral stem. Cemented Marathon acetabular cup. (DePuy).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Femoral neck fractures; Uncemented; Hydroxyapatite; Coated; Femoral; Stems; Hip fractures; THA; THR; Cemented; Fat embolism; Cognition; Inflammatory response; Mobilization