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A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Patients with Displaced Femoral Neck Fractures

A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Patients with Displaced Femoral Neck Fractures - HEALTH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42587
Enrollment
100
Registered
2015-08-07
Start date
2015-11-10
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

Femoral Neck Fractures

Interventions

A total hip arthroplasty versus a hemi-arthroplasty

Sponsors

McMaster University
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Aged 65 years or older. 2. Have a femoral neck fracture confirmed with anteroposterior (AP) and/or lateral hip radiographs, or computed tomography (CT), or magnetic resonance imaging (MRI). 3. Have a displaced fracture that is not repairable via reduction and internal fixation in the judgment of the attending surgeon 4. The operative treatment will take place within 3 days (i.e. 72 hours) of the patient being medically cleared for surgery. 5. Be ambulatory prior to fracture, though they may have used an aid. 6. Have anticipated medical optimization for arthroplasty of the hip (i.e. patient is cleared for surgery). 7. Provides informed consent 8. Have a low energy fracture (defined as a fall from standing height). 9. Have no other major trauma (defined as an Injury Severity Score

Exclusion criteria

Exclusion criteria: 1. The patient is not suitable for hemi*arthroplasty (e.g., inflammatory arthritis, rheumatoid arthritis, pathologic fracture [secondary to cancer], or severe osteoarthritis of the hip). 2. The patient has associated major injuries of the lower extremity (e.g. ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture). 3. The patient has retained hardware around the affected hip that will interfere with arthroplasty. 4. The patient has a soft tissue or bone infection around the hip. 5. The patient has a bone metabolism disorder other than osteoporosis (e.g., Paget*s disease, renal osteodystrophy, osteomalacia). 6. The patient has a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e. revision surgery at 2 years). 7. There may be problems with maintaining follow*up (e.g., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support), in the judgment of the attending surgeon. 8. The fracture occurred as a result of an act of violence. 9. The patient is participating in another ongoing drug or surgical intervention trial. 10. The attending surgeon believes that there is another reason to exclude the patient.

Design outcomes

Primary

MeasureTime frame
The primary outcome is any unplanned secondary procedure within 2 years of the initial joint replacement surgery.

Secondary

MeasureTime frame
Secondary outcomes will include: Functional outcome quality of life mortality hip-related complications.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)