Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures

NCT ID: NCT02074969

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2012-05-31

Brief Summary

The purpose of this study is to assess the differences between two different types of devices for the treatment of unstable pertrochanteric hip fractures. The hypothesis of this study is, that patients who are treated with the proximal femoral Nail Antirotation (PFNA) have a better outcome and lower complication rates than patients treated with the Gamma Nail (GN3).

Detailed Description

This trial is a prospective randomized controlled study including the treatment of AO/OTA 31-A2 fractures in 200 patients with 2 different surgical devices. 100 patients are treated with a Gamma Nail 3 (GN3) (Stryker) the other 100 patients with a Proximal Femoral Nail Antirotation (PFNA) (Synthes).

All surgeries are performed by trauma surgeons at a Level 1 University Hospital. One hundred patients are randomized to the gamma nail and 100 are randomized to the proximal femoral nail for treatment fixation. A 1:1 randomization is performed using sealed envelopes (200 in total), which are opened by the surgeon immediately before the operation.

Patients missing an informed consent form, incomplete chart, or showing a pathologic fracture are getting excluded from final comparisons.

Patients anthropometric data as well as pre-injury mobility assessments, and ASA will be documented. Furthermore the time from admission to going to surgery, surgery length, length of stay and mobility assessment at dischargement are recorded.

After surgery the stay in the hospital is documented precisely and patients are scheduled for next appointments 2 weeks, 6 weeks, 3 months, 6 months and 1 year after surgery.

Postoperative X-rays are measured precisely to determine the Tip-Apex Distance (TAD), the Parkers-Ratio, the Singh-Score and the Neck-Shaft-Angle of the injured and contralateral side. Rates of complications as cut-out and reoperation-rates are evaluated. All intra-operative complications are noted and included in the chart.

Conditions

Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gamma Nail 3

Gamma Nail 3 Stryker.

Group Type: ACTIVE_COMPARATOR

Gamma Nail 3

Intervention Type: DEVICE

Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.

PFNA

PFNA Antirotation Synthes

Group Type: ACTIVE_COMPARATOR

PFNA

Intervention Type: DEVICE

Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA.

Interventions

Gamma Nail 3

Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.

Intervention Type: DEVICE

PFNA

Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA.

Intervention Type: DEVICE

Other Intervention Names

Gamma Nail 3 Stryker; PFNA Antirotation Synthes

Eligibility Criteria

Inclusion Criteria

• AO/OTA 31-A2 fractures
• age between 18 - 100 years
• Signed written informed consent and agreement to attend the planned FUs
• Able to understand and read country national language at an elementary level

Exclusion Criteria

• missing informed consent form
• pathological fracture
• incomplete patient record
• death within one month of intervention (surgery)
• prior surgery to the hip
• polytrauma
• any additional fracture
• any implant at the same hip
• infection

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Harry Widhalm

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harald K. Widhalm, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Trauma, Medical University of Vienna, Austria

Locations

Department of Trauma, Medical University of Vienna

Vienna, Austria, Austria

Countries

Austria

References

Barton TM, Gleeson R, Topliss C, Greenwood R, Harries WJ, Chesser TJ. A comparison of the long gamma nail with the sliding hip screw for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur: a prospective randomized trial. J Bone Joint Surg Am. 2010 Apr;92(4):792-8. doi: 10.2106/JBJS.I.00508.

Reference Type: RESULT

PMID: 20360500 (View on PubMed)

Other Identifiers

2007406

Identifier Type: -

Identifier Source: org_study_id