Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate (TSP)

St. Olavs Hospital

Status: Completed

Conditions: Femoral Fractures

Treatments: Procedure: Addition of TSP to DHS

Study type: Interventional

Funder types: Other

Identifiers

NCT00626470

TSP Study

Details and patient eligibility

About

Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.

Enrollment: 100 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
• (can include; Patients with cognitive problems (ie. dementia etc)

Exclusion criteria

• Patients with pathological fractures
• Multitrauma patients
• Patients not able to walk before the fracture
• Under 19 years old.
• Patients with fractures needing other treatments than gliding hip screws
• Reverse oblique fractures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

-TSP

Active Comparator group

Description:

Patients operated without TSP

Treatment:

Procedure: Addition of TSP to DHS

+TSP

Active Comparator group

Description:

Patients operated with TSP

Treatment:

Procedure: Addition of TSP to DHS