A Prospective Clinical Study to Evaluate Safety and Performance of an Intra-Surgical Hydraulic Distractor During Spinal Surgeries.

Abstract

Introduction: Spinal surgeries often require the manipulation of bone structures while at the same time protecting sensitive tissues. Existing surgical systems involve manual force, which has a high risk of damaging the vertebrae and instruments interfere with the visibility between the vertebrae, which complicates work. The OrtoWell^® Distractor System, an intra-surgical hydraulic tool for vertebrae separation, offers incremental and stable force control and better visibility during distraction procedures in spinal surgeries. This study aims to fill the gap of still pending clinical trials using the device, by evaluating performance and safety of it across lumbar and thoracic surgeries.

Materials and methods: This study is a prospective, single-arm, multi-center observational study and was conducted between April 2018 and April 2023 at 3 German sites in patients undergoing anterior or lateral spinal surgery requiring vertebral separation. The device's safety and usability were assessed through surgeon-completed questionnaires on the device and its subcomponents, clinical outcomes and cardiovascular assessments. Assessments were conducted at four time points, at baseline, time of the index procedure, discharge and at a 30-day follow-up.

Results: 31 patients (13 males, mean age 62.33) were included. Single and multi-level treatments were performed using different accesses. The device facilitated spinal surgeries without any complications or device-related adverse events. Usability, stability and force control were evaluated as uniformly positive and all procedures proceeded as planned. Mean applied pressure was 147.69±29.48 bar. There were no major delays in surgical time and a mean blood loss of 215.17±113.57 cc. Cardiovascular parameters remained stable, with no significant changes between baseline and follow-up. Hospital stays averaged 16.39±10.25 days. Surgeons unanimously reported that the distractor simplified surgery.

Discussion and conclusions: The investigated device demonstrated high safety and performance, enabling precise force control and simplifying spinal surgeries. These findings suggest that hydraulic distractors could enhance surgical outcomes by improving intraoperative control and reducing procedural challenges.

Trial registration: Registered at ClinicalTrials.gov (NCT03501810, 12 Mar 2018).