Status unknownNCT057392403PASUpdated Mar 1, 2023

Effects of Preoperative 3D Printing of Distal Intra-articular Radius Fractures on Quality of Fracture Reduction

An interventional study of Osteosynthesis in Distal Radius Fracture and 3D Printing, sponsored by Vilijam Zdravkovic. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-01.

Sponsored by Vilijam Zdravkovic · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The investigators aim to evaluate the effect of a preoperative 3D printed Model (3PAS) of distal intraarticular radius fractures on quality of fracture reduction. Surgical procedure is equal in the 3PAS and in the conventional group. To evaluate the quality of fracture reduction each patient receives a postoperative CAT-scan.

Conditions studied

Distal Radius Fracture
3D Printing

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In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 80 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

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Lead sponsor

This is the only study on the registry with Vilijam Zdravkovic as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Patient older than 18 years
Surgery criteria fulfilled
Informed consent
Intra-articular Fracture of the distal radius (AO 23-B and 23-C) (also including Avulsion of the processus styloideus ulnae AO/OTA 2U3A1.1) in preoperative CAT-Scan

Exclusion criteria

Exclusion Criteria:

Patient does not want a surgical treatment
Patient does not want to participate
Positive history for surgery due to injury of the hurt wrist beforehand
Positive history for surgery due to injury of the opposite wrist beforehand
Additional injuries to the hand and forearm (except distal ulna fracture AO 2U3A1.1)
Pregnancy
Vulnerable people
Distal ulna fracture (except AO 2U3A1.1)
Extraarticular radius fracture (AO 23-A)
Concomitant injuries which interfere with the planned aftercare (intubated for a long time, additional elbow or shoulder fracture)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 80 participants (estimated)

Study arms

Other
no 3D model
Procedure: Osteosynthesis
Other
3D model
Procedure: Osteosynthesis

Interventions

ProcedureOsteosynthesis
Osteosynthesis of distal radius fractures

What researchers measure

Primary outcomes

Articular step-off of the distal radius joint surface in the postop CAT-scan
Time frame: 6 weeks
Articular gap of the distal radius joint surface in the postop CAT-scan
Time frame: 6 weeks

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05739240
Lead sponsor: Vilijam Zdravkovic
Responsible party: Vilijam Zdravkovic (Principal investigator, Cantonal Hospital of St. Gallen) — Sponsor-investigator
First posted: Feb 22, 2023
Start date: Mar 1, 2023 (estimated)
Primary completion: Mar 31, 2024 (estimated)
Completion: Mar 31, 2025 (estimated)
Last update: Mar 1, 2023

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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