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Cemented versus non-cemented hemiarthroplasty of the hip as a treatment for a displaced femoral neck fracture; a multi center randomised trial.


- candidate number4296
- NTR NumberNTR1508
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-okt-2008
- Secondary IDsABR number NL19200.098.07
- Public TitleCemented versus non-cemented hemiarthroplasty of the hip as a treatment for a displaced femoral neck fracture; a multi center randomised trial.
- Scientific TitleCemented versus non-cemented hemiarthroplasty of the hip as a treatment for a displaced femoral neck fracture; a multi center randomised trial.
- ACRONYMTo Cement or Not?
- hypothesisWe hypothesise that not using bone cement in hemiarthroplasty for proximal femoral fractures in elderly patients will at least have comparable functional outcomes and complications with a shorter operation time.
- Healt Condition(s) or Problem(s) studiedFracture , Femoral fractures, Femoral fracture, Cement, Medial collum fracture, Hemiarthroplasty
- Inclusion criteria1. Age > 70 years;
2. Displaced femoral neck fracture;
3. ASA I- IV patient.
- Exclusion criteria1. Pathological fracture;
2. Fracture > 7 days old;
3. ASA V patient.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-aug-2008
- planned closingdate1-aug-2010
- Target number of participants200
- InterventionsRandomisation to either a cemented hemiarthroplasty Muller (Zimmer) or a non cemented hemiarthroplasty, DB 10 (Biomet).
- Primary outcome1. Duration of surgery is defined as skin-to-skin surgical time, measured in minutes;
2. Functional outcome is measured by the Time-Up-and Go (TUG) score and the Groningen Activity Restriction Scale (GARS);
3. Postoperative mid thigh pain is measured by a 4 -point ordinal scale (non/mild/ moderate/ severe) score. Mid thigh pain is defined as pain explicit in the front and mid part of the femur.
- Secondary outcome1.Living situation at final follow up, measured in percentage of pre-fracture situation;
2. Self reported health-related quality of life, measured by the SF 12;
3. Standard radiological evaluation of hemiarthroplasty and cement positioning and adequate size of the hemiarthroplasty measured on plain AP and axial X-rays of the operated hip. Adequate AP positioning is defined as less than 10 degrees varus or valgus. Adequate axial positioning is defined as 0 to 15 degrees anteversion.
- Timepoints1. Follow up of 1 year;
2. Measurements at 0,6,12 and 52 weeks.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. P. Pilot
- CONTACT for SCIENTIFIC QUERIESDr. P. Pilot
- Sponsor/Initiator Reinier de Graaf Gasthuis, Delft , Rijnstate Ziekenhuis, Canisius Wilhelmina Hospital, St. Elisabeth Hospital, Tilburg
- Funding
(Source(s) of Monetary or Material Support)
St. Elisabeth Hospital, Tilburg, Canisius-Wilhelmina hospital, Rijnstate Hospital, Reinier de Graaf Gasthuis, Delft
- PublicationsN/A
- Brief summaryBased on the recent Cochrane analysis no preference can be found for using a non cemented or a cemented hemiarthroplasty. This study has been designed to compare a cemented and a non cemented hemiarthroplasty as a treatment for a displaced femoral neck fracture. The results of this trial will be published as soon as they become available.
- Main changes (audit trail)
- RECORD27-okt-2008 - 21-nov-2009


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