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Advantages of 3D Printing in the Management of Acetabular Fractures

Primary Purpose

Acetabular Fracture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fractures of the posterior structures of the acetabulum treated by fixation using the Kocher-Langenbeck approach.
Sponsored by
University Tunis El Manar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acetabular Fracture focused on measuring Acetabulum

Eligibility Criteria

23 Years - 57 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    3D printing group

    conventional technique group

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    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)
    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.
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 11, 2020
    Last Updated
    December 2, 2020
    Sponsor
    University Tunis El Manar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04660734
    Brief Title
    Advantages of 3D Printing in the Management of Acetabular Fractures
    Official Title
    Advantages of 3D Printing in the Management of Acetabular Fractures Fixed by the Kocher Langenbeck Approach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    February 28, 2019 (Actual)
    Study Completion Date
    February 28, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Tunis El Manar

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acetabular Fracture
    Keywords
    Acetabulum

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two techniques for treatment of posterior structure of acetabular fracture
    Masking
    ParticipantOutcomes 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
    Allocation
    Randomized
    Enrollment
    109 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    3D printing group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    conventional technique group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Fractures of the posterior structures of the acetabulum treated by fixation using the Kocher-Langenbeck approach.
    Intervention Description
    Fracture fixation of posterior structures of acetabulum by using the surgical procedure of Kocher-Langenbeck approach
    Primary Outcome Measure Information:
    Title
    Quality of fracture reduction
    Description
    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)
    Time Frame
    30 months with minimum of 18 months
    Title
    radiographic criteria
    Description
    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.
    Time Frame
    30 months with minimum of 18 months
    Title
    Clinical score
    Description
    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
    Time Frame
    30 months with minimum of 18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    23 Years
    Maximum Age & Unit of Time
    57 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mondher Kooli, PhD
    Organizational Affiliation
    Orthopedic and traumatologic department of Charles Nicolle Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No: There is not a plan to make IPD available.
    Citations:
    PubMed Identifier
    32458075
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    30128670
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    35103815
    Citation
    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.
    Results Reference
    derived

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