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Three-dimensional virtual surgical planning and patient-specific osteosynthesis with drilling guides for acetabular fracture surgery

Three-dimensional virtual surgical planning and patient-specific osteosynthesis with drilling guides for acetabular fracture surgery - DREAM-3D

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54324
Enrollment
150
Registered
2020-08-04
Start date
2021-05-05
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Hip joint/hip

Interventions

The intervention group will be surgically treated with patient-specific implants and the control group will be surgically treated with conventional implants.

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients >= 18 years with an acute (2 weeks from the injury) displaced acetabular fracture will be included after a signed informed consent. - Elementary acetabular fracture types (isolated posterior wall, isolated posterior column, anterior wall, anterior column and transverse fractures) - Associated type acetabular fracture types (posterior column and wall, transverse and posterior wall, T-type, anterior column and posterior hemitransverse, both column fractures).

Exclusion criteria

Exclusion criteria: - *Late* acetabular fractures more than 2 weeks after the injury - Pathological fractures - Patient with previous hip surgery or surgery in the pre-peritoneal space (Stoppa approach) making an anterior or posterior pelvic approach hardly possible. - Patient unfit for acetabular surgery (e.g. anterior and posterior approach in one tempi). - Patients with body-mass index (BMI) >35.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the residual fracture displacement (in mm), as measured on the postoperative CT-scan.

Secondary

MeasureTime frame
The secondary endpoint includes patient reported outcome, which will be assessed with validated follow-up questionnaires at one-year follow-up. Additionally, surgery related factors e.g. operation time, intraoperative blood loss, and complications. For the patient-specific implants, the accuracy of the screw positions will be assessed by matching the preoperative virtual planning with the post-operative CT images.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)