Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up
|ClinicalTrials.gov Identifier: NCT00764153|
Recruitment Status : Completed
First Posted : October 1, 2008
Last Update Posted : October 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Femoral Neck Fractures||Procedure: Bipolar hemiarthroplasty Procedure: Internal fixation||Not Applicable|
Patients were included from 2002-2004. Two years follow up was finished by 2006. Patients with displaced intracapsular femoral neck fractures were included and randomized by means of closed numbered envelopes to operation groups:
- Two parallel screws (Olmed).
- Hemiarthroplasty with Charnley/ Hastings prosthesis.
A priori one would expect that there would be less morbidity and mortality with the less extensive and quicker operation with parallel screw and that a faster and better rehabilitation would be achieved with hemiarthroplasty.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||December 2011|
Closed reduction and internal fixation with two parallel screws (Olmed)
Procedure: Internal fixation
Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)
Other Name: Olmed (DePuy)
Hemiarthroplasty with Charnley/ Hastings prosthesis
Procedure: Bipolar hemiarthroplasty
Lateral approach. FWB.
Other Name: Charnley/Hastings
- Harris Hip Score [ Time Frame: 5-6 years ]
- Eq-5d [ Time Frame: 5-6 years ]
- Barthel Index [ Time Frame: 5-6 years ]
- Reoperations and complications [ Time Frame: 5-6 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00764153
|Study Chair:||Jan Erik Madsen, MD PhD||Orthopedic Center, Ulleval University Hospital, Oslo, Norway|