Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures (PROGAINT-ES)
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ClinicalTrials.gov Identifier: NCT00736684 |
Recruitment Status :
Completed
First Posted : August 18, 2008
Last Update Posted : February 11, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Unstable Trochanteric Fractures | Device: Proximal Femoral Nail AntirotationTM (PFNA) Device: Gamma Nail 3TM (Gamma3) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 440 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Proximal Femoral Nail Antirotation™ (PFNA) Versus Gamma Nail 3™ (Gamma3) for Intramedullary Nailing of Unstable Trochanteric Fractures - a Multicenter Randomized Controlled Trial |
Study Start Date : | November 2007 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | September 2010 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Proximal Femoral Nail AntirotationTM (PFNA)
|
Device: Proximal Femoral Nail AntirotationTM (PFNA)
intramedullary nailing |
2
Gamma Nail 3TM (Gamma3)
|
Device: Gamma Nail 3TM (Gamma3)
intramedullary nailing |
- Any fracture fixation complication. [ Time Frame: One year ]
- Bone union/fusion as evaluated by CT-scanning, health-related quality of life, disease-specific functional scoring, activities of daily living, mortality, radiological parameters, surgery details and surgeons' evaluation of handling and effectiveness. [ Time Frame: One year ]

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Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 55 years and more
- Patients with isolated, unstable, closed or type 1 open trochanteric fractures, classified as AO 31-A2 or AO 31-A3
- Definitive primary fracture treatment with PFNA or Gamma3 (defined inTable 1) within three days after the index event
- Signed written informed consent (by the subjects or legal guardian) and agreement to attend the planned follow-ups
Exclusion Criteria:
- Pathologic fracture of any other cause than osteoporosis
- Patients or legal guardian refusing to sign the informed consent form
- Multiple trauma
- Type 2 and 3 open fractures
- Drug or alcohol abuse
- Wound and/or bone healing disorders of any other cause than diabetes mellitus or smoking
- Active malignancy
- Expected life expectancy ≤ 3 months
- Inability to walk independently prior to injury event (use of one stick is allowed. Not meeting inclusion criteria are bedridden, wheel-chair ridden and walker dependent subjects)
- Neurological and psychiatric disorders that would preclude reliable assessment (eg,, Parkinson disease, Multiple sclerosis, severe depression)
- Rheumatoid arthritis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00736684
Spain | |
Hospital Universitario "Marqués de Valdecilla" | |
Santander, Cantabria, Spain, 39008 | |
Hospital Clinic | |
Barcelona, Cataluña, Spain, 08036 | |
Hospital Gregorio Marañon | |
Madrid, Spain, 28007 | |
Hospital Puerta de Hierro | |
Madrid, Spain, 28035 | |
H.U. Virgen de la Arrixaca | |
Murcia, Spain, 30071 | |
Hospital Donostia | |
San Sebastián, Spain, 20014 |
Study Director: | Beate P. Hanson, MD | AO Clinical Investigation and Documentation, Davos, Switzerland | |
Principal Investigator: | Javier Vaquero Martin, MD | Hospital Gregorio Marañon, Madrid, Spain |
Responsible Party: | Javier Vaquero Martin, MD, Hospital Gregorio Marañon |
ClinicalTrials.gov Identifier: | NCT00736684 |
Other Study ID Numbers: |
PROGAINT-ES-08 |
First Posted: | August 18, 2008 Key Record Dates |
Last Update Posted: | February 11, 2011 |
Last Verified: | February 2011 |
Femoral fractures [MeSH] hip fractures [MeSH] trochanteric fractures (femoral neck fractures [MeSH]) intramedullary nailing (fracture fixation, intramedullary [MeSH]) |
complex femoral fractures femoral nail surgical treatment (surgical procedures, operative [MeSH]) complications |
Fractures, Bone Hip Fractures Wounds and Injuries |
Femoral Fractures Hip Injuries Leg Injuries |