Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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 ]
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): NCT00764153
|Study Chair:||Jan Erik Madsen, MD PhD||Orthopedic Center, Ulleval University Hospital, Oslo, Norway|