Clinical Trial: A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures

Brief Summary:

There is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly

No definite conclusions have been made in regards to what kind of arthroplasty is favourable

Cemented implants are associated with increased risk of perioperative cardiovascular incidents and increased mortality.

Cementless implants are associated with increased postoperative pain and decreased walking ability.

This study investigates the differences between one well-documented cemented femoral stem and one well-documented uncemented femoral stem. Previous studies have mostly used uncemented stems with different designs.

Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5 years


Detailed Summary:

Inclusion Criteria: Dislocated intracapsular femoral neck fracture in patients ≥ 70 years old Exclusion criteria: Pathological fracture, Systemic or local infection, Short life expectancy/not mobile at all, Symptomatic coxarthrosis.

Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year (SD of HHS is 15 points) Power: 95% Significance: 0.05 60 patients in each group needed. To compensate for high mortality and drop-out: 200 patients, 100 in each group

Randomized using www.randomization.org to create sealed opaque envelopes opened at inclusion after signed informed concent.

Recorded after surgery:

Operating time Arthroplasty components used Need of blood transfusion Blood loss Size of incision

Recorded at discharge, 3 months, 1 year and 5 years:

X-ray of pelvis and hip Harris Hip Score Barthels ADL-index Quality of life (EQ-5D) Use of analgetics Use of walking aids

Publication: International orthopaedic journal.


Sponsor: Ullevaal University Hospital

Current Primary Outcome: Functional outcome including pain (Harris Hip Score) [ Time Frame: 5 years ]

Original Primary Outcome: Functional outcome including pain (Harris Hip Score) [ Time Frame: 1 year ]

Current Secondary Outcome:

  • All Cause Mortality [ Time Frame: 5 years ]
  • Activities Of Daily Living (Barthels ADL-Index) [ Time Frame: 5 years ]
  • Quality Of Life (EQ-5D) [ Time Frame: 5 years ]
  • Any treatment related complication [ Time Frame: 5 years ]


Original Secondary Outcome:

  • All Cause Mortality [ Time Frame: One Year ]
  • Activities Of Daily Living (Barthels ADL-Index) [ Time Frame: One Year ]
  • Quality Of Life (EQ-5D) [ Time Frame: 1 Year ]
  • Any treatment related complication [ Time Frame: One year ]


Information By: Ullevaal University Hospital

Dates:
Date Received: June 25, 2007
Date Started: September 2004
Date Completion: December 2010
Last Updated: September 23, 2010
Last Verified: September 2010