Operative Treatment of 2-fragment-fractures (AO 11-A3) of the Proximal Humerus in the Elderly: Cement Augmented Locking Plate Philos vs. Proximal Humerus Nail MultiLoc

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT02609906
• Date of registration: 18/11/2015
• Prospective Registration: No
• Primary sponsor: Klinikum der Universitaet Muenchen
• Public title: Operative Treatment of 2-fragment-fractures (AO 11-A3) of the Proximal Humerus in the Elderly: Cement Augmented Locking Plate Philos vs. Proximal Humerus Nail MultiLoc
• Date of first enrolment: November 2015
• Target sample size: 40
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02609906
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Tobias Helfen, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age: =60 years or younger postmenopausal woman

- 2-fragment-fracture according to AO-classification AO 11-A3

- Signed informed consent

- Patient can read and understand German

Exclusion Criteria:

- Refusal to participate in the study

- Not Independent

- Dementia and/or institutionalized

- Does not understand written and spoken guidance German

- Pathologic fracture or a previous fracture of the same proximal humerus

- Alcoholism or drug addiction, e.g., in the emergency department, breathalyzer
indicates blood alcohol concentration of more than 2%

- Other injury to the same upper limb requiring surgery

- Major nerve injury (e.g., complete radial- or axillary nerve palsy)

- Rotator cuff tear arthropathy

- Open fracture

- Multi-trauma or -fractured patient

- Fracture dislocation or head-splitting fracture

- Non-displaced fracture

- Isolated fracture of the major or minor tubercle

- Gross displacement of the fracture fragments (no bony contact between fracture parts
or the humeral shaft is in contact with the articular surface)

- Any medical condition that excludes surgical treatment

- Pregnancy



Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Bone Plates

Shoulder Fractures

Intramedullary

Intervention(s)

Device: MultiLoc®-Nail (Depuy-Synthes)

Device: PhilosTM with augmentation (Depuy-Synthes)

Primary Outcome(s)

Disabilities of the Shoulder, Arm and Hand-Score (DASH) [Time Frame: 24 months]

Secondary Outcome(s)

Short Form 36 (SF-36) [Time Frame: 24 months]

Barthel Index [Time Frame: 24 months]

Range of motion (ROM) [Time Frame: 24 months]

American Shoulder and Elbow Score (ASES) [Time Frame: 24 months]

Constant Score (CS) [Time Frame: 24 months]

Oxford Shoulder Score (OSS) [Time Frame: 24 months]

Secondary ID(s)

510-15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors