Endoscopic Strip Craniectomy for Craniosynostosis

Overseen By Betty Tung, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Over 6 months old

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day (surgery)

150 Participants Needed

Trial Summary

What is the purpose of this trial?

* Endoscopic strip craniectomy (ESC) with post-operative helmeting is the gold-standard treatment for isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age as it is has been demonstrated to reduce perioperative morbidity when compared to more invasive procedures such as cranial vault remodeling. ESC is frequently performed with or without the use of lateral osteotomies with technical selection being largely based on surgeon preference. * Previous studies have shown that there are no statistically significant differences in cranial expansion or complications between the two procedure variants; however, these studies are retrospective in nature and do not account for aesthetic outcomes. * The purpose of this study is to compare the efficacy of ESC with or without the use of lateral osteotomies in regard to cranial expansion and aesthetic outcomes for children treated with isolated, non-syndromic sagittal craniosynostosis. In addition, we seek to investigate if there are any observable changes in perioperative morbidity between the two procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is endoscopic strip craniectomy generally safe for humans?

Endoscopic strip craniectomy is considered a minimally invasive procedure and is generally deemed safe, but there are reports of complications and the need for further investigation into its safety and outcomes. ^{1 2 3 4 5}

How is endoscopic strip craniectomy with helmet therapy different from other treatments for craniosynostosis?

Endoscopic strip craniectomy with helmet therapy is a minimally invasive treatment for craniosynostosis that uses small incisions and an endoscope (a thin tube with a camera) to remove the fused skull suture, followed by helmet therapy to shape the skull as it heals. This approach is less invasive than traditional open surgery, potentially reducing recovery time and complications, and it can be performed with a single incision, offering cosmetic benefits and minimizing wound issues. ^{1 3 4 6 7}

Research Team

David F Bauer, MD, MPH

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for babies under 6 months old with a condition called isolated, non-syndromic sagittal craniosynostosis. They must be patients at Texas Children's Hospital and able to have the surgery before reaching 6 months of age.

Inclusion Criteria

My child has a skull condition and is under 6 months old.

Exclusion Criteria

I cannot have a specific skull surgery by 6 months old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endoscopic strip craniectomy with or without lateral osteotomies, followed by post-operative helmeting

1 day (surgery)

1 visit (in-person for surgery)

Post-operative Monitoring

Standard post-operative visits and measurements of cephalic index using the STARscanner©, along with chart reviews

30 days

Multiple visits (in-person)

Follow-up

Participants are monitored for cranial expansion and aesthetic outcomes at 1 year post-operatively

1 year

1 visit (in-person)

Treatment Details

Interventions

• Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy
• Endoscopic strip craniectomy (without lateral osteotomies) with post-operative helmet therapy
• Endoscopic strip craniectomy with post-operative helmet therapy

Trial Overview The study compares two surgical methods for treating sagittal craniosynostosis: endoscopic strip craniectomy (ESC) both with and without lateral osteotomies, followed by helmet therapy. It aims to see which method is better for skull shape and safety.

Participant Groups

Group I: Endoscopic strip craniectomy without the use of lateral osteotomies Experimental Treatment 1 Intervention

Patients will NOT have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.

Group II: Endoscopic strip craniectomy with the use of lateral osteotomies Active Control 1 Intervention

Patients will have lateral osteotomies incorporated into their surgical procedure following suturectomy of the fused sagittal suture.

Endoscopic strip craniectomy (with lateral osteotomies) with post-operative helmet therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Endoscopic Strip Craniectomy for:

• Isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age

Approved in United States as Endoscopic Strip Craniectomy for:

• Isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age
• Syndromic craniosynostosis in selected cases

Approved in Canada as Endoscopic Strip Craniectomy for:

• Isolated, non-syndromic sagittal craniosynostosis in children under 6 months of age

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Findings from Research

Endoscopic strip craniectomy, while introduced as a safe and effective method for treating craniosynostosis, has shown cases where patients required additional surgery due to inadequate initial treatment, highlighting potential limitations of the procedure.

An informal survey of craniofacial specialists revealed discrepancies between published outcomes and real-world experiences regarding complications, indicating a need for more thorough research to clarify the effectiveness and safety of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Strip Craniectomy for Craniosynostosis: Do We Really Understand the Indications, Outcomes, and Risks? Kung, TA., Vercler, CJ., Muraszko, KM., et al.[2018]

Patients with sagittal craniosynostosis (SC) completed helmet therapy at a younger age (7.88 months) and for a shorter duration (4.17 months) compared to those with metopic craniosynostosis (MC), who required therapy until 10 months and for 6 months.

The type of craniosynostosis significantly affects the duration and number of helmets needed for postoperative therapy, with MC patients needing longer and more helmets than SC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Helmeting Therapy Duration After Endoscopic Strip Craniectomy for Metopic and Sagittal Craniosynostosis. Nguyen, HT., Washington, GN., Cepeda, A., et al.[2023]

A study of 100 infants with craniosynostosis showed that minimally invasive endoscopic strip craniectomies are safe, with no major complications and a low average blood loss of 26.2 mL during surgery.

The procedure, combined with helmet molding therapy, effectively normalizes craniofacial deformities, allowing most patients to be discharged the day after surgery, making it a valuable alternative to traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early management of craniosynostosis using endoscopic-assisted strip craniectomies and cranial orthotic molding therapy. Jimenez, DF., Barone, CM., Cartwright, CC., et al.[2022]

Endoscopically assisted wide-vertex strip craniectomy is a safe and effective treatment for sagittal craniosynostosis, showing comparable outcomes to open calvarial vault reconstruction, with a significantly shorter operating time (88 minutes vs. 179 minutes) and reduced blood loss (29 ml vs. 218 ml).

Patients undergoing the endoscopic procedure had a shorter hospital stay (1.2 days vs. 3.9 days) and lower transfusion rates (6.4% for endoscopic vs. 100% for open surgery), indicating a lower morbidity associated with the endoscopic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopically assisted versus open repair of sagittal craniosynostosis: the St. Louis Children's Hospital experience. Shah, MN., Kane, AA., Petersen, JD., et al.[2022]

A case study of a two-month-old baby who underwent surgery for sagittal synostosis revealed that inconsistent use of an orthotic helmet after surgery may lead to complications, including the development of pansynostosis, which required further surgical intervention.

The findings emphasize the need for proper parent education and regular follow-up appointments to monitor helmet therapy and prevent potential complications in craniofacial treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancraniosynostosis following endoscopic-assisted strip craniectomy for sagittal suture craniosynostosis in the setting of poor compliance with follow-up: a case report. Sivakumar, W., Goodwin, I., Blagg, R., et al.[2018]

A retrospective study of 13 patients undergoing minimally-invasive nonendoscopic suturectomy for craniosynostosis showed that the procedure is safe, with only one mild intraoperative complication and no postoperative complications, while maintaining a short hospital stay of about 1.77 days.

Long-term follow-up indicated significant improvements in skull shape and symmetry, comparable to results from endoscopic techniques, suggesting that nonendoscopic suturectomy is an effective alternative for treating nonsyndromic craniosynostosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suturectomies Assisted by Cranial Orthosis Remodeling for the Treatment of Craniosynostosis Can Be Performed Without an Endoscope. Olshinka, A., Har-Shai, L., Novitski, I., et al.[2021]

The single-incision endoscopic strip craniectomy for treating sagittal craniosynostosis in infants offers cosmetic benefits and lowers the risk of wound complications compared to the traditional two-incision method.

This technique enhances endoscopic visualization, which helps minimize blood loss during surgery, an important factor given the limited blood volume in young infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single incision endoscopic strip craniectomy for sagittal craniosynostosis. Ahn, ES., Bhandarkar, AR.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Endoscopic Strip Craniectomy for Craniosynostosis: Do We Really Understand the Indications, Outcomes, and Risks? [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Helmeting Therapy Duration After Endoscopic Strip Craniectomy for Metopic and Sagittal Craniosynostosis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Early management of craniosynostosis using endoscopic-assisted strip craniectomies and cranial orthotic molding therapy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Endoscopically assisted versus open repair of sagittal craniosynostosis: the St. Louis Children's Hospital experience. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Pancraniosynostosis following endoscopic-assisted strip craniectomy for sagittal suture craniosynostosis in the setting of poor compliance with follow-up: a case report. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Suturectomies Assisted by Cranial Orthosis Remodeling for the Treatment of Craniosynostosis Can Be Performed Without an Endoscope. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Single incision endoscopic strip craniectomy for sagittal craniosynostosis. [2022]