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

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.

Study Overview

• Status: Completed
• Conditions: Acetabular Fracture
• Intervention / Treatment: Procedure: Fractures of the posterior structures of the acetabulum treated by fixation using the Kocher-Langenbeck approach.

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.

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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
Experimental: 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.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Principal Investigator: Mondher Kooli, PhD, Orthopedic and traumatologic department of Charles Nicolle Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Acetabulum
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 01031972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No