Evaluation of an Innovative Medical Device Supporting Orthopedic Surgical Interventions (VIPS)

Siemens

Status: Completed

Conditions: Fracture of Distal End of Radius

Treatments: Procedure: Treatment with surgical standard of care; Procedure: Treatment with investigational method (virtual implant positioning system)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01670344

10308644 Final 2.5

Details and patient eligibility

About

This study is a randomized, controlled, 2-arm, open trial to evaluate an innovative positioning system in the clinical setting of orthopedic surgery.

Aim of the study is the validation and comparison of the innovative medical device with the current standard method.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with diastal fracture of the radius
• Patients with the mentioned fracture and indication for surgical treatment according to national guidelines
• Age >/= 18 years of age
• Patients willing to participate and after having given their informed consent in written form

Exclusion criteria

• Participation in other interventional clinical trials
• Pregnant or lactating women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

A

Other group

Description:

Treatment with investigational method (virtual implant positioning system)

Treatment:

Procedure: Treatment with investigational method (virtual implant positioning system)

B

Other group

Description:

Treatment with surgical standard of care

Treatment:

Procedure: Treatment with surgical standard of care