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Assessing the effect of a hybrid spinal fusion surgery with novel techniques on disability and pain in adults with spinal disc injury.

Assessing the clinical importance of sagittal balance on disability and pain in adults undergoing a novel hybrid transforaminal lumbar interbody fusion surgical technique.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001154493
Enrollment
55
Registered
2025-10-22
Start date
2026-01-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This longitudinal study will evaluate surgical and patient outcomes following a Hybrid Transforaminal Lumbar Interbody Fusion (TLIF) performed by A/Prof Paul Licina at Brisbane Private Hospital. The Hybrid TLIF integrates the benefits of both open and minimally invasive techniques to enhance surgical precision and recovery. Using advanced technologies — including the CIRQ robotic alignment module, EOS imaging, and the SpineHUB digital education app — the study will capture comprehensive surgical, functional, and patient-reported outcomes. By combining robotic guidance, 3D imaging, and digital engagement, this research aims to provide new insights into optimising spinal fusion surgery and improving patient experience. Findings will help inform best practice and future innovation in spine care.

Interventions

This is a longitudinal observational study designed to evaluate outcomes in patients undergoing a Hybrid Transforaminal Lumbar Interbody Fusion (TLIF) surgical technique performed by A/Prof Paul Licina at Brisbane Private Hospital. Importantly, this study does not involve any experimental intervention or alteration to usual clinical care. The Hybrid TLIF technique, use of the CIRQ robotic alignment module, the SpineHUB patient education app, and the collection of standard perioperative outcomes

This is a longitudinal observational study designed to evaluate outcomes in patients undergoing a Hybrid Transforaminal Lumbar Interbody Fusion (TLIF) surgical technique performed by A/Prof Paul Licina at Brisbane Private Hospital. Importantly, this study does not involve any experimental intervention or alteration to usual clinical care. The Hybrid TLIF technique, use of the CIRQ robotic alignment module, the SpineHUB patient education app, and the collection of standard perioperative outcomes are all already part of routine clinical practice at SpinePlus and Brisbane Private Hospital. The Hybrid TLIF procedure has been performed by A/Prof Licina in routine practice prior to study initiation in candidates he determines are suitable. This surgical technique is well-documented. It combines aspects of both “open” and “minimally invasive” TLIF approaches — providing full visual access for decompression and cage insertion on the decompression side, and a minimally invasive approach on the contralateral side to reduce soft tissue disruption. The CIRQ robotic alignment module is routinely used to assist with minimally invasive screw placement in these hybrid TLIF procedures. The SpineHUB app is also routinely used to deliver pre- and post-operative patient education, information, and surveys for all surgical patients. The app covers topics such as: an introduction to the healthcare team, diagnosis and surgical procedure, preparation for surgery, recovery and return to work, potential complications, medications, BackSpace rehabilitation, exercises, and discharge planning. Educational content is delivered through a mix of written materials and videos, tailored to the participant’s stage of care (e.g., considering, tentative, confirmed, pre-op, post-op, discharge). App analytics will be used to track and monitor participant engagement. This study is purely observational and aims only to collect and analyse data on surgical, functional, and patient-reported outcomes among patients who are already scheduled to undergo a Hybrid TLIF procedure. No randomisation, allocation, or alteration of treatment will occur. If a patient chooses not to participate, their surgery and post-operative care will proceed as usual with no impact on their management. The only difference for this study is that we will collect a more comprehensive set of data to formally evaluate outcomes associated with the Hybrid TLIF procedure. This includes perioperative outcomes, complication rates, and short- and long-term clinical outcomes. Participants will complete pain and medication use questionnaires (twice daily for 8 weeks post-operatively, then weekly until 6 months), wear a Fitbit to track activity, and undergo functional capacity testing pre-operatively and at 6 months post-operatively. Imaging (including EOSedge scans) and surgical notes will be used to monitor alignment and procedural fidelity. All procedures and tools involved (Hybrid TLIF, CIRQ robot, SpineHUB app, and EOS imaging) are already routinely used in clinical care, supported by prior literature: • CIRQ robot use in spinal surgery: Desai & Adams (2022); Gabrovsky et al. (2023) • Digital apps for patient education: Venkatraman et al. (2022, 2023) • EOS imaging in orthopaedics: Illés & Somoskeöy (2012) Thus, this project is observational in nature, focused solely on monitoring and reporting outcomes from an existing and established surgical practice, without introducing any new or experimental interventions.

Sponsors

Adjunct Professor Paul Licina - Spine Plus
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adults greater than or equal to 18-years of age 2. Eligible to undergo a primary lumbar fusion surgery as determined by the Principal Investigator A/Prof Licina.

Exclusion criteria

1. Requires an extension or revision surgery 2. Requires a multi-level intervention 3. If the patient specific anatomy is unsuitable for a minimally invasive approach as determined by A/Prof Licina 4. Active workers compensation claim 5. Ineligible to participate in the study as determined by A/Prof Licina during the initial clinical exam

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026