Pilot study of Innotere Paste-CPC remodeling in humeral head fractures

Pilot study of Innotere Paste-CPC remodeling in humeral head fractures - RMIPHH

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025444

Enrollment

Registered

2021-05-28

Start date

2021-09-14

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

Humeral head fractures with defect zone

Interventions

Group 1: Treatment of the humeral head fracture with Innotere Paste-CPC (231IP1) and Arthrex PEEKPower humeral fracture plate for fixation as well as 2 additional radiological examinations by means of

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Humeral head fractures with metaphyseal defect; Signed informed consent; Age = 18 years

Exclusion criteria

Exclusion criteria: Osteolytic metastases; Rheumatic diseases; Infected bone defects; Multiple myeloma; Severe osteoporosis; Pregnancy / Lactation

Design outcomes

Primary

Measure	Time frame
Evaluation of remodeling by sequencing of two of two CT examinations (1st CT 48 hours postoperatively, 2nd CT 9 months postoperatively)	—

Secondary

Measure	Time frame
- Evaluation of the decompression cannula and the handling of the Innotere Paste-CPC in daily surgery - Osteointegration of calcium phosphate cement during possible biopsy in the course of implant removal	—

Countries

Germany

Contacts

Public ContactAnke Zimmermann

Universitätsklinikum Gießen und Marburg GmbH, Klinik und Poliklinik für Unfall-, Hand- und Wiederherstellungschirurgie

studien.unfallchirurgie@chiru.med.uni-giessen.de+49 (0) 641 99 44668

Outcome results

None listed

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