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

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ClinicalTrials.gov Identifier: NCT01578408
Recruitment Status : Recruiting
First Posted : April 17, 2012
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Femoral Neck Fractures Procedure: Total Hip Arthroplasty Device: Cemented Lubinus SPII stem (control arm) Device: Uncemented HA Coated Corail stem

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2010
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Uncemented HA Coated Corail stem
Surgery with an inversed hybrid arthroplasty with an uncemented hydroxyapatite coated Corail stem and a cemented Marathon cup (DePuy).
Procedure: Total Hip Arthroplasty Device: Uncemented HA Coated Corail stem
Uncemented hydroxyapatite coated Corail femoral stem. Cemented Marathon acetabular cup. (DePuy).
Active Comparator: Cemented Lubinus SPII stem (control arm)
Surgery with a totally cemented option with a Lubinus SPII stem and a IP cup (Link).
Procedure: Total Hip Arthroplasty Device: Cemented Lubinus SPII stem (control arm)
Cemented Lubinus femoral stem. Cemented IP acetabular cup. (Link).


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Reoperation. [ Time Frame: Postoperatively up to 10 years. ]
    In case of for example infection or dislocation.

  7. 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.


Eligibility Criteria

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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are acutely admitted to hospital with dislocated femoral neck fractures, that in clinical praxis are in the need of hip prosthesis surgery, are recruited in the study. The fracture shall not engage the lesser nor the greater trochanters.
  • Patients who wants to participate in the study and who can consider participation for at least 1 year.
  • Coming from independent dwelling conditions.
  • Not dementia.
  • Circa 60-85 years of age.
  • Circa 50 patients in each arm/group shall be included at Mölndal's Hospital (part of Sahlgrenska University Hospital).

Exclusion Criteria:

  • Patients who have difficulties in understanding the intent of the study.
  • Rheumatic disorders (RA, Bechterew, SLE).
  • Cortison treatment.
  • Stroke with remaining weakness or neurological disorders with affection of locomotion.
  • Dementia.
  • Grave obesity with BMI >=30-35.
  • Delay between time of injury and time of surgery exceeding 72 hours.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578408


Contacts
Contact: Arun Patel, MD +46 31 343 08 55 arun.patel@vgregion.se
Contact: Johan Kärrholm, Prof MD PhD +46 31 342 82 47 johan.karrholm@vgregion.se

Locations
Sweden
Mölndals Hospital (part of Sahlgrenska University Hospital) Recruiting
Mölndal, Sweden, 43180
Contact: Arun Patel, MD    +46 31 343 08 55    arun.patel@vgregion.se   
Contact: Johan Kärrholm, Prof MD PhD    +46 31 342 82 47    johan.karrholm@vgregion.se   
Principal Investigator: Arun Patel, MD         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
DePuy Orthopaedics
Investigators
Study Director: Johan Kärrholm, Prof MD PhD Orthopaedic Department, Sahlgrenska University Hospital, Gothenburg, SWEDEN
More Information

Responsible Party: Arun Patel, MD, Senior Physician in Orthopaedic Surgery, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01578408     History of Changes
Other Study ID Numbers: Corail-SP Study
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Arun Patel, MD, Sahlgrenska University Hospital, Sweden:
Femoral neck fractures
Uncemented
Hydroxyapatite
Coated
Femoral
Stems
Hip fractures
THA
THR
Cemented
Fat embolism
Cognition
Inflammatory response
Mobilization

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