Hip Fractures Treated With Uncemented Arthroplasties

Phase 2

• Conditions: Femoral Neck Fractures

• Registration Number: NCT01798472
• Lead Sponsor: Stockholm South General Hospital

Brief Summary

The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties.

The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.

Detailed Description

Femoral neck fracture is a common cause of suffering and premature mortality among the elderly. Riskfactors for femoral neck fractures are age, gender, osteoporosis and cognitive dysfunction.

Mortality and morbidity varies between undisplaced and displaced femoral neck fractures.

Different treatment options are available: reduction and internal fixation vs joint replacement (arthroplasty). The treatment of undisplaced femoral neck fractures is uncontroversial and consists of internal fixation with screws.

The treatment of displaced, femoral neck fractures with internal fixation shows unacceptable results with complications rates leading to reoperation between 40-60%. Treatment of these fractures with arthroplasties has therefore become the standard treatment in industrial countries.

Fixation of the femoral component with bone-cement is standard procedure in Europe today. To avoid negative cardio-pulmonary events in patients with serious comorbidities and in very old and frail patients uncemented femoral components or internal fixation are used. These uncemented stems are mostly older design with poor track records. The use of modern, well-documented stems used in an osteoarthritis population for fracture patients has still to be tested.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-15
• Last Update Posted: 2015-01-16
• Primary Completion: 2016-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• displaced fracture of the femoral neck
• independent living
• independent ambulation (with or without walking aids)

Exclusion Criteria

• pathological fracture
• severe dementia (defined as ≤3 in short portable mental questionnaire) preoperatively
• preexisting ipsilateral hip disease
• neurological disease (e.g. M. Parkinson)
• psychiatric disease which makes understanding or following instructions impossible
• history of drug and alcohol abuse

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Harris Hip Score	12 month	Our primary outcome variable is the Harris Hip Score at 12 month follow up. Harris Hip Score is an investigator reported tool evaluating hip function in four dimensions: Pain, function, absence of deformity and range of motion

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	12 month	We use the patient reported instrument EQ-5D. A questionnaire consisting of 5 questions to evaluate health related quality of life.
Radiological follow up	12 month	Evaluation of radiological outcome on standard hip radiographies with focus on bony ingrowth, signs of loosening and subsidence

Trial Locations

Locations (1)

Södersjukhuset (South general hospital), Department of orthopedic surgery; 🇸🇪 Stockholm, Sweden