Intramedullary Devices for the Treatment of Unstable Pert... | NCT02074969

Studies
Intramedullary Devices for the Treatment of Unstable Pertrochanteric Fractures

NCT02074969

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Mar 3, 2014Estimated

Enrollment

200Actual

Phase

Not Applicable

Conditions

Fractures

Interventions

Gamma Nail 3
PFNA

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Dec 2010Actual

Completion Date

May 2012Actual

First Submitted Date

Feb 27, 2014

First Submission Date that Met QC Criteria

Feb 28, 2014

First Posted Date

Mar 3, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2014

Last Update Posted Date

Mar 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Harry Widhalm, M.D., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gamma Nail 3	Active Comparator	Gamma Nail 3 Stryker.	Device: Gamma Nail 3
PFNA	Active Comparator	PFNA Antirotation Synthes	Device: PFNA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gamma Nail 3	Device	Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.	Gamma Nail 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
re-operation rate		time between intervention and one year after

Secondary Outcomes

Measure	Description	Time Frame
Screw-Cut Out	evaluation of sliding movements of the hip screw in the sense of a cut-out	time between intervention and one year after

Other Outcomes

Measure	Description	Time Frame
Mobility assessment	Mobility assessment includes scoring of pre-operative level of mobility and mobility after intervention	time between hospitalization and one year after intervention

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Harald K. Widhalm, M.D.	Department of Trauma, Medical University of Vienna, Austria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Trauma, Medical University of Vienna		Vienna	Austria	1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20360500	Result	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.