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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Sahlgrenska University Hospital, Sweden
Sponsor:
Collaborator:
DePuy Orthopaedics
Information provided by (Responsible Party):
Arun Patel, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01578408
First received: April 11, 2012
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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 Intervention
Femoral Neck Fractures
Device: Lubinus SPII / IP
Device: Corail / Marathon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arthoplasty in Patients With Femoral Neck Fractures

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • Time to mobilization. [ Time Frame: During hospital stay, an expected average of 10 days. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    Questionnaires regarding Patient's satisfaction, Quality of life (EQ-5D), Activity level (UCLA), Harris Hip Score.


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Uncemented Hydroxyapatite Coated Corail stem
Surgery with an inversed hybrid arthroplasty with an uncemented hydroxyapatite coated Corail stem and a cemented Marathon cup (DePuy).
Device: Corail / Marathon
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).
Device: Lubinus SPII / IP
Cemented Lubinus femoral stem. Cemented IP acetabular cup. (Link).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Arun Patel, Senior Physician in Orthopaedic Surgery, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01578408     History of Changes
Other Study ID Numbers: Corail-SP Study
Study First Received: April 11, 2012
Last Updated: April 13, 2012
Health Authority: United States: Food and Drug Administration
Sweden: Regional Ethical Review Board

Keywords provided by 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:
Femoral Neck Fractures
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on August 28, 2014