Advantages of 3D Printing in the Management of Acetabular Fractures

NCT04660734 | Completed

• 1 other identifier: 01031972
• Study Type: interventional
• Target: 109
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acetabular Fracture

Keywords

Acetabulum

Outcome Measures

Primary Outcomes (3)

• Quality of fracture reduction

  CT 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)

  30 months with minimum of 18 months

• radiographic criteria

  Matta 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.

  30 months with minimum of 18 months

• Clinical score

  Modified 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

  30 months with minimum of 18 months

Study Arms (2)

3D printing group

EXPERIMENTAL

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.

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

conventional technique group

EXPERIMENTAL

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.

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

Interventions

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

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

3D printing group; conventional technique group

Eligibility Criteria

• Age: 23 Years - 57 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Tunis El Manar: lead

Related Publications (3)

• 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.

  PMID: 32458075 BACKGROUND

• 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.

  PMID: 30128670 RESULT

• 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.

  PMID: 35103815 DERIVED

Study Officials

• Mondher Kooli, PhD

  Orthopedic and traumatologic department of Charles Nicolle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Two techniques for treatment of posterior structure of acetabular fracture

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: December 9, 2020
• Study Start: September 1, 2016
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: December 9, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share