Clinical Trial: Cemented Versus Uncemented Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Corail-SP Study - A Prospective Randomized Comparison Between Cemented and Uncemented Hydroxyapatite Coated Prosthesis Stems in Total Hip Arthroplasty in Patients With Femoral Neck Fractures

Brief 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 Summary:

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).

Sponsor: Sahlgrenska University Hospital, Sweden

Current Primary Outcome: Time to mobilization. [ Time Frame: During hospital stay, an expected average of 10 days. ]

Time (days) to mobilization defined as independent walking with or without walking aids measured by ward physiotherapist with Traffic Light System and Sahlgrenska University Hospital Hip Score (SUHS).


Original Primary Outcome:

  • Time to mobilization. [ Time Frame: During hospital stay, an expected average of 10 days. ]
    Time (days) to mobilization defined as independent walking with or without walking aids measured by ward physiotherapist with Traffic Light System and Sahlgrenska University Hospital Hip Score (SUHS).
  • Cognitive status. Eventual confusion. [ Time Frame: During hospital stay, an expected average of 10 days. ]

    Cognitive status measured once daily with Pfeiffer's test (Short Portable Mental Status Questionnaire - SPMSQ).

    Eventual confusion is noted once daily.

  • Oxygen saturation levels peroperatively. [ Time Frame: Peroperatively (during surgery), an expected average of 2 hours. ]
    POX-measurements during different phases of surgery along with pulmonary catheter readings.
  • Bone remodeling around the hip prosthesis. [ Time Frame: Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years. ]
    Measurements with hip DXA.
  • Biomarkers / inflammatory response. [ Time Frame: Preoperatively in average 4 hours. Peroperatively at end of wound closure. Postoperatively 1, 3, 5, 7 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years. ]
    Blood samples for measurement of the inflammatory response with biochip multi‐array technology.
  • Fixation / migration / loos

    Current Secondary Outcome:

    • Cognitive status. Eventual confusion. [ Time Frame: During hospital stay, an expected average of 10 days. ]

      Cognitive status measured once daily with Pfeiffer's test (Short Portable Mental Status Questionnaire - SPMSQ).

      Eventual confusion is noted once daily.

    • Oxygen saturation levels peroperatively. [ Time Frame: Peroperatively (during surgery), an expected average of 2 hours. ]
      POX-measurements during different phases of surgery along with pulmonary catheter readings.
    • Bone remodeling around the hip prosthesis. [ Time Frame: Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years. ]
      Measurements with hip DXA.
    • Biomarkers / inflammatory response. [ Time Frame: Preoperatively in average 4 hours. Peroperatively at end of wound closure. Postoperatively 1, 3, 5, 7 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years. ]
      Blood samples for measurement of the inflammatory response with biochip multi‐array technology.
    • Fixation / migration / loosening of the hip prosthesis components. [ Time Frame: Postoperatively in average after 2 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years. ]
      Measured by radiostereometric analysis (RSA) in addition to the conventional pelvis and hip X-ray exams. Early radiological loosening of one or both of the prosthesis components is identified at an early stage with RSA.
    • Reoperation. [ Time Frame: Postoperatively up to 10 years. ]
      In case of for example infection or dislocation.
    • PROM - Patient Reported Outcome Measurements. [ Time Frame: Preoperatively in average 4 hours. Postoperatively at discharge from hospital at an expected average of 10 days. All follow up visits at 3, 6 months, 1, 2, 5, 7, 10 years. ]
      Questionnaires regarding Patient's satisfaction, Quality of life (EQ-5D), Activity level (UCLA), Harris Hip Score.


    Original Secondary Outcome:

    Information By: Sahlgrenska University Hospital, Sweden

    Dates:
    Date Received: April 11, 2012
    Date Started: May 2010
    Date Completion: December 2023
    Last Updated: May 28, 2015
    Last Verified: May 2015