Treatment With a New Nail or a Sliding Hip Screw Clinical Trial
Official title:
A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures
| Verified date | September 2010 |
| Source | Haukeland University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Norway:Social Science Data Services |
| Study type | Interventional |
This is a study to compare the new nail "INTERTAN" with a Sliding Hip Screw in treating a
specific group of hipfractures (trochanteric and subtrochanteric fractures).
Are there differences in terms of pain, early and late functional mobility and complications
between the to implants (and methods of operation)?
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | March 2010 |
| Est. primary completion date | March 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: - Patients older than 60 years with a trochanteric or subtrochanteric hip fracture. Exclusion Criteria: - Patients with pathologic fractures, patients already included with a fracture on the opposite side. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Norway | Orthopaedic dep, Haukeland University Hospital | Bergen |
| Lead Sponsor | Collaborator |
|---|---|
| Haukeland University Hospital |
Norway,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Early postoperative pain (VAS)(and functional mobility (TUG-test)) | 1 week postoperative | No | |
| Secondary | Pain, functional mobility (TUG-test), Harris Hip Score, quality of life (EQ-5D) and complications at discharge from hospital,and at 6 weeks,3 and 12 months postop. | 1 year follow up | No |