CEMENTED VERSUS NON CEMENTED HEMIARTHROPLASTY OF THE HIP AS A TREATMENT FOR A DISPLACED FEMORAL NECK FRACTURE; A RANDOMISED TRIAL

CEMENTED VERSUS NON CEMENTED HEMIARTHROPLASTY OF THE HIP AS A TREATMENT FOR A DISPLACED FEMORAL NECK FRACTURE; A RANDOMISED TRIAL - cemented vs uncemented hemiarthroplasty

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39179

Enrollment

200

Registered

2007-11-20

Start date

2008-08-14

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hip fracture

Interventions

Intervention (if applicable): Patients with a displaced femoral neck fracture will be divided in two groups. One group will be treated with a cemented hemiarthroplasty, the other group with a non ce

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - age 70 years and up. - dislocated femoral neck fracture not older than 7 days - displacedfemoral neck fracture suited for treatment hemiarthroplasty - informed consent signed by patient or legal representative - Medical condition allowing surgery - ASA I-IV

Exclusion criteria

Exclusion criteria: - pathological fractures - Non displaced femoral neck fractures - fractures that are older than 7 days - ASA V.

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints - Duration of surgery is defined as skin to skin surgical time, measured in minutes. - Complications are divided in major and minor complications. These are described in section 6 and appendix I. - Functional outcome is measured by the Time-Up-and Go (TUG) score and the Groningen Activity Restriction Scale (GARS). - Postoperative mid thigh pain 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.	—

Measure

Time frame

Main study parameters/endpoints - Duration of surgery is defined as skin to skin surgical time, measured in minutes. - Complications are divided in major and minor complications. These are described in section 6 and appendix I. - Functional outcome is measured by the Time-Up-and Go (TUG) score and the Groningen Activity Restriction Scale (GARS). - Postoperative mid thigh pain 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.

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Secondary

Measure	Time frame
Secondary Objective(s): - Living situation at final follow up, measured in percentage of pre-fracture situation. An ordinal scale will be used. - 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 the same as or less than 15 degrees anteversion, 0 degrees retroversion.	—

Measure

Time frame

Secondary Objective(s): - Living situation at final follow up, measured in percentage of pre-fracture situation. An ordinal scale will be used. - 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 the same as or less than 15 degrees anteversion, 0 degrees retroversion.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)