Advantages of 3D Printing in the Management of Acetabular Fractures

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.

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Key information

Conditions

Acetabular Fracture

Age range

23 year–57 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

Quality of fracture reduction

Time frame: 30 months with minimum of 18 months
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

Time frame: 30 months with minimum of 18 months
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

Time frame: 30 months with minimum of 18 months
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

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Dec 9, 2020
Registry last updated: Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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