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NCT Number: NCT06811532

Assessing Perfusion of Osteotomized Scapula and Lat Flap

The gold standard for reconstruction of the jaw is the utilization of a bone free tissue transfer. Scapula reconstruction is an excellent option for elderly patients, those with significant comorbidities and for complex defects with large soft tissue reconstructive requirements. The scapula is supplied by the angular artery and circumflex scapula arteries. No studies have shown with objective measures, the viability of the lateral border of the scapula bone supplied by either the angular artery or circumflex scapula arteries. The aim of this observational study is to demonstrate with objective clinical measures, via SPY-Q software analysis, that the angular artery can adequately supply the scapula tip flap including with a single osteotomy giving two bone segments, in 30 patients who will undergo reconstructive head and neck surgery at LHSC.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The aim of this follow-up observational study is to demonstrate with objective clinical measures via SPY-Q software analysis, that the angular artery can adequately supply the scapula tip flap including a single distal osteotomy segment. 30 patients undergoing mandible or maxillary reconstruction with the scapular tip flap will be included. An osteotomy will be performed at up to 8cm from the scapular tip. The adequacy of blood supply to the scapula tip flap after a distal osteotomy and the latissimus dorsi muscle component of the flap will be measured intraoperatively, using SPY-Q software analysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • • Adult patients (18 years and older) seen at the head and neck clinic at London Health Sciences Centre (LHSC)
  • Planned to undergo a maxillary and/or mandibular reconstruction surgery with a scapular tip flap

Exclusion criteria

  • • Younger than 18 years of age
  • History of failing microvascular flaps
  • Hypersensitivity toward ICG or related substances (e.g., imaging agents), defined as (based on ICG product monograph): possibly life-threatening dizziness, severe itching, hives, nausea, difficulty breathing, rash, low blood pressure)
  • Pregnant
  • Breastfeeding
  • Clinically apparent cognitive impairment

Treatment and study plan

Blood perfusion analysis using SPY-Q software

Other

Use of the SPY-Q analysis software during surgery to calculate bone profusion scores on several areas of the scapular tip flap (endosteum of scapula bone segments and latissimus dorsi muscle component).

Primary outcomes

  1. Adequacy of blood perfusion of osteomized lateral border of the scapula bone supplied by the angular artery

    Time frame: Intra-operatively

    To measure the adequacy of blood perfusion of osteotomised lateral border of the scapula bone supplied by the angular artery via SPY-Q analysis in patients undergoing a scapular tip flap for reconstruction of a jaw defect

  2. Blood perfusion of osteomized lateral border of the scapula

    Time frame: Intra-operatively

    To measure the adequacy of blood perfusion of osteotomised lateral border of the scapula bone supplied by the angular artery via SPY-Q analysis in patients undergoing a scapular tip flap for reconstruction of a jaw defect

Secondary outcomes

  1. To assess flap viability

    Time frame: Intra-operatively; up to 10 days post-operatively

    To evaluate whether scapular tip flaps with an osteotomy with adequate bone perfusion scores resulted in surgical success (flap viability)

  2. Concordance between subjective and objective measure of blood perfusion

    Time frame: Intra-operatively; up to 10 days post-operatively

    To assess the concordance between visual inspection of blood perfusion and SPY-Q analysis of blood perfusion

  3. Blood perfusion of latissmus dorsi

    Time frame: Intra-operatively

    To measure the adequacy of blood perfusion of the latissimus dorsi muscle component of the scapula flap via SPY-Q analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Agnieszka Dzioba, PhD

CONTACT

[email protected]

519-685-8500

Sponsors and collaborators

Lead sponsor

Western University, Canada

Other

Registry information

Official study title

Assessing Perfusion of an Osteotomised Scapula and Latissimus Dorsi Chimeric Free Flap on the Thoracodorsal Artery

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2025
Registry last updated
Apr 9, 2025

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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