Unstable Proximal Femoral Fracture Clinical Trial
— PFN-A| Verified date | February 2017 |
| Source | Corporacion Parc Tauli |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
1. Introduction:
Controversy exists with regard to whether to treat AO/OTA (Orthopaedic Trauma
Association) 32.A2 - 32-A3 fractures of the proximal part of the femur with an
intramedullary short PFN-A or long PFN-A. A prospective, randomized, controlled trial
is performed to compare the outcome treatment of these unstable fractures of the
proximal part of the femur with either a short PFN-A (170-240mm) or long PFN-A
(300-420mm).
2. Objectives and Hypothesis The hypothesis is that the Short PFN-A would have fewer
complications than Long PFN-A
Main Objective: Is defined as Total number of complications between PFN-A short and
PFN-A long. Outcome measures were subdivided into preoperative, perioperative and
post-operative. Follow up data at four weeks, three months and one year.
Secondary objectives: Complete and uneventful radiological and clinical healing of the
fracture. Revision operations (related to the failure of primary treatment) and
mortality. Baseline characteristics were documented pre-operatively: Outcome measures
were subdivided into intra-operative, post-operative and follow up data at four weeks,
three months and one year.
3. Methodology: One hundred and eighty eight patients presenting with an AO/OTA 31-A2 and
31-A3 fracture of the proximal part of the femur will be randomized, at the time of the
admission, to fixation with use either a short PFN-A or a long PFN-A.
| Status | Completed |
| Enrollment | 188 |
| Est. completion date | January 2017 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility |
Inclusion Criteria: - Patients 60 years old above. - Patients with trochanteric fracture 31.A2 and 31.A3 AO classification for long bones - Patients that accept to participate on the study under consent Exclusion Criteria: - Metaphyseal fractures with extension more than 3 cm in reference to lesser trochanter calibrated and analyzed with PreOPlan registered application. - Combination of fractures in the proximal femur. - Pathological fractures. - Diaphyseal femoral fractures. - Rejection of surgery by the patient. - Contraindications to the use of either implants studied. - Patients who do not wish to participate in this study |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitario Parc Taulí de Sabadell | Sabadell | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Ferran Fillat Gomà | Hospital Parc Taulí, Sabadell |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total number of complications between PFN-A short and PFN-A long | follow-up data is recruited at 4 weeks, 3 months and one | One year | |
| Secondary | Complete and uneventful radiological and clinical healing of the fracture and mortality | follow-up data is recruited at 4 weeks, 3 months and one year. | One year |