Skip to content

RSA study on trochanteric fractures: DHS versus gamma-nail.

Fixation device related rotational and translational influences in trochanteric femoral fractures: A radio stereometric analysis of the DHS versus the gamma-nail.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28524
Enrollment
60
Registered
2010-02-16
Start date
2010-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

treatment of trochanteric femur fractures

Interventions

Sixty patients, age >60 years, with an AO31-A2 type trochanteric fracture will be randomly allocated to treatment with either DHS or Gamma-nail. Intervention: Micromotion across the fracture site (

Sponsors

Leiden University Medical Centre (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged over 60; 2. AO31-A2 type trochanteric fracture; 3. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Aged under 60; 2. AO31-A1 or A3 type trochanteric fracture; 3. No informed consent; 4. Severe arthritis of the involved hip; 5. Reumatoid arthritis; 6. Pathological fracture; 7. Pre-existent immobility.

Design outcomes

Primary

MeasureTime frame
Main study parameters/endpoints: Parameters: Demographical data, co-morbidity, rotation and translation as determined on RSA radiographs, type of implant: intra-, or extra-medullary, position of the femoral head screw, bone density and adverse events. Primary endpoint: Rotation and translation as determined on RSA radiographs in relation to type of implant used: intra-, or extra-medullary.

Secondary

MeasureTime frame
Secondary endpoints: Micromotion in relation to the position of the femoral head screw and bone density. Local adverse events (cut-out, implant failure).

Contacts

Public ContactI.B. Schipper

Erasmus Medical Center, Trauma Center ZWN, room Z-9.15, P.O. Box 2040

i.schipper@erasmusmc.nl+31 (0)10 4635034

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)