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Dutch Research for the Evaluation of Acetabular fracture Management in 3D

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28665
Enrollment
150
Registered
2021-04-14
Start date
2021-04-19
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Acetabular fracture

Interventions

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

Sponsors

UMCG
Lead Sponsor

Eligibility

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. - 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: - Elementary acetabular fracture types (isolated posterior wall, isolated posterior column, anterior wall, anterior column and transverse fractures) - ‘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. the total time for intra-operative bending manoeuvres, plate positioning and fixation, the surgeon’s satisfaction about implant fitting will be assessed. 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.

Contacts

Public ContactAnne Meesters

UMCG

a.m.l.meesters@umcg.nl0503611885

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)