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Advantages of 3D Printing in the Management of Acetabular Fractures

Advantages of 3D Printing in the Management of Acetabular Fractures Fixed by the Kocher Langenbeck Approach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04660734
Enrollment
109
Registered
2020-12-09
Start date
2016-09-01
Completion date
2019-02-28
Last updated
2020-12-09

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

Conditions

Acetabular Fracture

Keywords

Acetabulum

Brief summary

Background: Acetabular fractures result from violent trauma, and their incidence has been increasing in recent years. The Kocher-Langenbeck surgical approach is used for the internal fixation of displaced fractures of the posterior structures of the acetabulum. The quality of the reduction and the stability of osteosynthesis directly influence the function of the repaired acetabulum. In the surgical management of acetabulum fractures, 3D printing of a bone model is increasingly used during preoperative planning by trauma surgeons worldwide. Questions: Is there a difference in the surgical time of the Kocher-langenbeck reduction and fixation of the posterior structures of the acetabulum between 3D printing (which allows for shaping of the reconstruction plate prior to surgery) and the conventional technique? Are there any differences in complications between the two techniques? Are there any short-term differences in the functional and radiographic scores between 3D printing and the conventional technique? Methods: 109 consecutive patients who sustained fractures of the acetabulum were screened for inclusion. 43 patient were studied. The first group (G1) consisted of 20 patients who underwent prior molding of the osteosynthesis plate on a 3D-printed model. The second group (G2 or control group) included 23 patients who underwent surgery using the conventional technique. We compared surgical time, intraoperative blood loss, the difference between pre- and postoperative hemoglobin, and the onset of early infection, paralysis of the sciatic nerve, and deep vein thrombosis.

Detailed description

This randomized, prospective study included 109 consecutive patients who were treated for fractures of the acetabulum between September 2016 and February 2019 at our institution. This study was approved by the ethics committee at our institution and verbal and written informed consent was obtained from all patients. The final analysis included 43 patients (33 males and 10 females) who underwent the Kocher-Langenbeck approach for the reduction and fixation of the posterior structures of the acetabulum. The patients were divided into two groups. Group 1 (G1) consisted of 20 patients who underwent preoperative molding of the osteosynthesis plate on a 3D printed model of the pelvis. Group 2 (G2 or control group) included 23 patients who underwent surgery using the conventional technique. All patients were examined in the outpatient department via clinical and radiographic evaluation at 3, 6, 12, and 24 weeks postoperatively, then every 6 months thereafter. A standard radiographic assessment including three views (AP, iliac oblique, and obturator oblique) and a pelvic CT scan were obtained for all patients at the last follow-up visit. The reductions were classified as one of three types: anatomical (residual displacement \<1 mm), imperfect (residual displacement 1 to 3 mm), and poor (residual reduction \>3 mm). Clinical outcomes were assessed using the modified Harris Hip score. Bone consolidation was obtained in all cases. Clinical and radiographic results at the last follow-up as well as the minimum follow-up duration were evaluated by one surgeon who did not participate in the surgical management of the patients.

Interventions

PROCEDUREFractures of the posterior structures of the acetabulum treated by fixation using the Kocher-Langenbeck approach.

Fracture fixation of posterior structures of acetabulum by using the surgical procedure of Kocher-Langenbeck approach

Sponsors

University Tunis El Manar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Clinical and radiographic results at the last follow-up were evaluated by one surgeon who did not participate in the surgical management of the patients

Intervention model description

Two techniques for treatment of posterior structure of acetabular fracture

Eligibility

Sex/Gender
ALL
Age
23 Years to 57 Years
Healthy volunteers
No

Inclusion criteria

* Fractures of the posterior structures of the acetabulum * treatment using the Kocher-Langenbeck approach.

Exclusion criteria

* age over than 60 years * treatment approach other than the Kocher-Langenbeck's ( eg orthopedic method) * open fractures of the pelvis * fractures of the acetabulum older than 3-weeks * polytrauma with/or multiple fractures. * unavailability for follow-up * insufficient clinical and radiographic data.

Design outcomes

Primary

MeasureTime frameDescription
Quality of fracture reduction30 months with minimum of 18 monthsCT scan displacement of fracture as one of three: * Anatomical (residual displacement \<1 mm) * Imperfect (residual displacement 1 to 3 mm) * Poor (residual reduction \>3 mm)
radiographic criteria30 months with minimum of 18 monthsMatta scoring system a grade of : * Excellent :indicates a normal appearance of the hip; * Good: mild changes, small osteophytes, moderate (one-millimeter) narrowing of the joint, and minimum sclerosis; a grade of * Fair:intermediate changes, moderate osteophytes, moderate (less than 50 per cent) narrowing of the joint, and moderate sclerosis; and a grade of * Poor: advanced changes, large osteophytes, severe (more than 50 per cent) narrowing of the joint, collapse or wear of the femoral head, and acetabular wear.
Clinical score30 months with minimum of 18 monthsModified Harris Hip Score includes the pain and function components: The maximum score of 91 is multiplied by 1.1 to give a total score out of 100 Modified Hip Harris score * Excellent: 90-100 * Good: 80-90 * Fair 70-80 * Poor: \<70

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026