Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Femur Fracture

Treatments: Procedure: internal fixation (inflatable PFN by DISCOTEC); Procedure: internal fixation (DHS - richard nail)

Study type: Interventional

Funder types: Other

Identifiers

NCT00686023

TASMC-08-ES-0054

Details and patient eligibility

About

Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood loss, operative complications and postoperative rehabilitation in the management of pertrochanteric femur neck fractures.

Full description

patients with pertrochanteric fractures of the femur will be randomly assigned to one of 2 groups.

group 1 will undergo internal fixation using a DHS device. group 2 will undergo internal fixation using an inflatable intramedullary femoral nail device post operative care will be the same including DVT prophylaxis, early mobilization.

weight baring will be aloud in cases of a stable fracture (EVANS 1-3) non weight bearing until callus bridge in patients with unstable fractures (EVANS 4-6)

outcomes: death within first year

postoperative complications length of hospitalization time to mobilization functional score reontgenic evaluation

Enrollment: 100 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pertrochanteric femur fracture
• Unilateral
• Age over 60 years
• Low energy trauma
• ASA score 0-3

Exclusion criteria

• Reverse oblique fractures
• Pathological fractures
• Severe osteoarthritis of the hip joint
• Previous operations on same leg
• ASA score 4-5

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Active Comparator group

Description:

DHS fixation

Treatment:

Procedure: internal fixation (DHS - richard nail)

2

Active Comparator group

Description:

IMN fixation

Treatment:

Procedure: internal fixation (inflatable PFN by DISCOTEC)