Advantages of 3D Printing in the Management of Acetabular Fractures

NCT ID: NCT04660734

Last Updated: 2020-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2019-02-28

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.

Conditions

Acetabular Fracture

Keywords

Acetabulum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

3D printing group

Group 1 (G1) consisted of 20 patients who underwent preoperative molding of the osteosynthesis plate on a 3D printed model of the pelvis. A preoperative scan of the healthy hemi-pelvis was used to create the 3D-printed model for patients in G1 according to the following three-step methodology: 1) A scanographic acquisition of images was performed using a multi-strip scanner in thin sections. These images were recorded as digital images in the standard medical format of digital imaging and communications ; 2) A digital, 3D model of the pelvis in the stereolithography format was created to digitally treat the 2D images. The individualization of the healthy hemi-pelvis, to which a "mirror effect" was applied allowed for the creation of a symmetrical 3D image, as hemi-pelvises are globally symmetrical. 3) A 3D printer was used to create a physical, 3D-printed model of the affected hemi-pelvis using polylactic acid.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

conventional technique group

Group 2 (G2 or control group) included 23 patients who underwent surgery using the conventional technique.The patients in the control group (G2) underwent surgery following the conventional procedure based on radiographic and CT images with 3D reconstructions.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Interventions

Fractures 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 57 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Bouabdellah

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mondher Kooli, PhD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic and traumatologic department of Charles Nicolle Hospital

References

Wang P, Kandemir U, Zhang B, Fei C, Zhuang Y, Zhang K. The effect of new preoperative preparation method compared to conventional method in complex acetabular fractures: minimum 2-year follow-up. Arch Orthop Trauma Surg. 2021 Feb;141(2):215-222. doi: 10.1007/s00402-020-03472-w. Epub 2020 May 26.

Reference Type: BACKGROUND

PMID: 32458075 (View on PubMed)

Hsu CL, Chou YC, Li YT, Chen JE, Hung CC, Wu CC, Shen HC, Yeh TT. Pre-operative virtual simulation and three-dimensional printing techniques for the surgical management of acetabular fractures. Int Orthop. 2019 Aug;43(8):1969-1976. doi: 10.1007/s00264-018-4111-8. Epub 2018 Aug 20.

Reference Type: RESULT

PMID: 30128670 (View on PubMed)

Bouabdellah M, Bensalah M, Kamoun C, Bellil M, Kooli M, Hadhri K. Advantages of three-dimensional printing in the management of acetabular fracture fixed by the Kocher-Langenbeck approach: randomised controlled trial. Int Orthop. 2022 May;46(5):1155-1163. doi: 10.1007/s00264-022-05319-y. Epub 2022 Feb 1.

Reference Type: DERIVED

PMID: 35103815 (View on PubMed)

Other Identifiers

01031972

Identifier Type: -

Identifier Source: org_study_id