The Quality of Fracture Reduction with the Intra-Operative Use of the 3D-RX-System in fractures of the extremities

The Quality of Fracture Reduction with the Intra-Operative Use of the 3D-RX-System in fractures of the extremities - EF3X Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35256

Enrollment

700

Registered

2009-11-17

Start date

2009-10-02

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

fractuurdiagnostiek and ankle. intra-articular fractures of calcaneus wrist

Interventions

All included patients will be subjected to additional intra-operative 3D-RX. In half of the patients the surgeon will be blinded to these results, in the other half the surgeon may use the 3D-RX res

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults Traumatic intraarticular fracture of wrist, ankle or calcaneus Informed consent

Exclusion criteria

Exclusion criteria: Pathological fractures Mentally or physically unable to comply with the trial requirements

Design outcomes

Primary

Measure	Time frame
1. Quality of fracture reduction on postoperative CT-scans 2. Diagnostic value according to a standard protocol of judging the postoperative CT-scans and intra-operative 2D-fluoroscopy and 3D-scans. The scores of the intraoperative scans and postoperative CT-scans will be compared. 3. Cost-effectiveness of 3D-Rx vs. 2D-scanning and CT.	—

Secondary

Measure	Time frame
• The number and sort of corrections made after 2D-fluoroscopy • The number and sort of corrections made after a 3D-scan • The number of revision operations • The number and sort of complications • The fluorotime • The duration of the operation • The length of the hospital stay expressed in days • Duration until full mobilization of the joint expressed in weeks • The range of motion in degrees; for the ankle plantar and dorsal flexion and in- and eversion; for the wrist the palmar and dorsal flexion and ulnar and radial deviation after week 6,12 and 26 weeks and at 2 and 5 years postoperatively. • The strength of the operated joint compared to the contralateral joint after week 6, 12 and 26,and at 2 and 5 years postoperatively. • The clinical outcome by the DASH-score for the wrist and the FAOS-score for the ankle after week 6,12 and 26, and at 2 and 5 years postoperatively. • The pain score after 1, 6, 12 and 26 weeks, and at 2 and 5 years postoperatively by means of the VAS-score. • The degree of posttraumatic arthrosis at 5 years postoperatively, judged on a CT-scan of the operated joint	—

Measure

Time frame

• The number and sort of corrections made after 2D-fluoroscopy • The number and sort of corrections made after a 3D-scan • The number of revision operations • The number and sort of complications • The fluorotime • The duration of the operation • The length of the hospital stay expressed in days • Duration until full mobilization of the joint expressed in weeks • The range of motion in degrees; for the ankle plantar and dorsal flexion and in- and eversion; for the wrist the palmar and dorsal flexion and ulnar and radial deviation after week 6,12 and 26 weeks and at 2 and 5 years postoperatively. • The strength of the operated joint compared to the contralateral joint after week 6, 12 and 26,and at 2 and 5 years postoperatively. • The clinical outcome by the DASH-score for the wrist and the FAOS-score for the ankle after week 6,12 and 26, and at 2 and 5 years postoperatively. • The pain score after 1, 6, 12 and 26 weeks, and at 2 and 5 years postoperatively by means of the VAS-score. • The degree of posttraumatic arthrosis at 5 years postoperatively, judged on a CT-scan of the operated joint

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)