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NCT02657902 Clinical Trial

Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Fractures With Gamma 3 Nail?

Hip Fractures Clinical Trial

Official title:
Does an Additional Antirotation U-Blade (RC) Lagscrew Improve Treatment of AO/OTA (Orthopaedic Trauma Association) 31 A1-3 Classified Fractures With Gamma 3 Nail?

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02657902
Other study ID # 1960/2015
Secondary ID
Status Completed
Phase N/A
First received January 8, 2016
Last updated January 15, 2016
Start date January 2009

Study information
Verified date January 2016
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial Summary

The purpose was to evaluate whether the additional use of the Gamma3 ® RC Lag Screw is associated with a reduced cutout rate in patients with OTA/AO 31A1-3 inter-trochanteric fractures.

Recruitment information / eligibility
Status Completed
Enrollment 135
Est. completion date
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- OTA/AO 31A1-3 fractures treated with Gamma 3® Nail (Stryker Trauma Germany) and either with standard lagscrews or with the Gamma3 ® RC Lag Screw (Stryker Trauma Germany)

Exclusion Criteria:

- Patients with pathological fractures

- Patients treated with a long gamma nail were excluded

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Fractures were treated with a Gamma 3 intramedullary nail

• Fractures were treated with a Gamma 3 intramedullary nail + U-Blade

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Outcome
Type Measure Description Time frame Safety issue
Primary Cutout rate Differences in the Cutout rate of the femoral head screw with/without U-Blade antirational screw 3 months after intervention No
Secondary Mobility Mobility of the patients 3 months after intervention measured with the Parker mobility score 3 months after intervention No
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