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PEEK (Polyetheretherketon) power plate for the treatment of proximal humerus fractures: a prospective study and comparison to fixation with a conventional locking plate

PEEK (Polyetheretherketon) power plate for the treatment of proximal humerus fractures: a prospective study and comparison to fixation with a conventional locking plate

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011376
Enrollment
60
Registered
2016-11-25
Start date
2016-10-26
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

S42.2

Interventions

Group 1: Treatment of the proximal humerus fracture with a PEEK plate Group 2: Treatment of the proximal humerus fracture with a conventional locking plate

Sponsors

Berufsgenossenschaftliche Unfallklinik Tübingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Operative Treatment of a proximal humerus fracture with a locking plate at the Medical Center BGU Tübingen

Exclusion criteria

Exclusion criteria: - patient refuses participation - patient is younger than 18 years - bilateral or former fractures of the proximal humerus - head split fractures or impression fractures of the humeral head - Cuff arthropathy of the contralateral or ipsilateral proximal humerus - injuries of nerves or blood vessels - known thrombophilia, severe heart diseases or severe pulmonary diseases - known hypersensitivities or allergies against one of the components wich are used - severe systemic diseases: class 4-6 of the American Society of Anesthesiologists (ASA) classification - severe systemic diseases class 3 of the ASA classification wich are not medically treated - acute or former drug addiction - participation in a clinical study wich could influence the results of this study

Design outcomes

Primary

MeasureTime frame
The primary outcome is the determination of the osseous consolidation shown in the X-ray image. For this all patients will get a X-ray image 6 weeks, 12 weeks, 6 months and 12 months after operative treatment.

Secondary

MeasureTime frame
The secondary outcome is the determination of the funcional outcome of the operative treatment. Funtional outcomes of patients will be recorded with the help of standardized scores. For this all patients will be examined 6 weeks, 12 weeks, 6 months and 12 months after the operative treatment.

Countries

Germany

Contacts

Public ContactMarkus Gühring

Berufsgenossenschaftliche Unfallklinik Tübingen

mguehring@bgu-tuebingen.de07071/606-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026