Assessment of the performance and clinical importance of 3D printed patient specific guides in distal radius malunion surgery

Assessment of the performance and clinical importance of 3D printed patient specific guides in distal radius malunion surgery - PSGs in radius malunion surgery

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54451

Enrollment

Registered

2020-11-04

Start date

2020-12-31

Completion date

Unknown

Last updated

2024-09-23

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

Conditions

Radius Malunion Residual malalignment after Radius fracture

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: The patient will undergo/underwent distal radius correction osteotomy surgery with the use of PSGs designed in OCON Centre of Orthopaedic Surgery.

Exclusion criteria

Exclusion criteria: The patient has a contraindication for CT scans.

Design outcomes

Primary

Measure	Time frame
To assess the performance of distal radius osteotomies, two 3D angles are generated. One 3D angle is generated between the preoperative and the planned orientation and one between the preoperative and postoperative orientation. These 3D angles will be used to find the coherence between the planning and the operative result which will be statistically tested using a non-inferiority margin. These results will be compared to patient related outcome measures to find the coherence between surgical result and patient satisfaction. This coherence will be tested using a Pearson correlation (normal distribution) or Spearman correlation (non-normal distribution).	—

Measure

Time frame

To assess the performance of distal radius osteotomies, two 3D angles are generated. One 3D angle is generated between the preoperative and the planned orientation and one between the preoperative and postoperative orientation. These 3D angles will be used to find the coherence between the planning and the operative result which will be statistically tested using a non-inferiority margin. These results will be compared to patient related outcome measures to find the coherence between surgical result and patient satisfaction. This coherence will be tested using a Pearson correlation (normal distribution) or Spearman correlation (non-normal distribution).

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Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results