Clinical trial NCT05250024: Synthetic Cranioplasty PEEK Versus UHMWP
Official title: Cranioplasty Using Patient Specific Implants Polyether Ether Ketone Versus Ultra-High Molecular Weight Polyethylene: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cranium; Deformity
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 22
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to report the investigators experience with synthetic reconstruction of cranial defects using computer guided milled UHMWP, in terms of benefits and limitations both clinically and radiographically in comparison to PEEK implants.

Detailed description: Statement of the problem:

To this date, there is still no consensus on the ideal material for cranial reconstruction. Research journey involved the use of autologous grafts, allografts, xenografts, and a wide array of synthetic materials for cranioplasty. The autologous bone flap, although associated with less infection than allo or xenografts, is not always a possibility after comminution or osteomyelitis and still has the common drawbacks of storage, aseptic bone flap necrosis (ABFR) and the need for a second surgery. Titanium offers lower cost but is quite difficult to shape, radiopaque and exhibits high dehiscence with thin skin biotypes. Polyetheretherketone (PEEK) has been gaining popularity during the recent years for lower rates of graft failure, however, it still holds a risk of postoperative inflammatory complications, is of exceedingly high cost most studies utilizing it are retrospective and observational.

Rationale for conducting the research:

Cranioplasty procedures carry functional and esthetic challenges and the most suitable graft to be used remains controversial. UHMWP use in biomedical applications is greatly due to its outstanding mechanical properties and biocompatibility which, when coupled with three D computer guided milling technology to reconstruct complex and large cranial defects, can provide durable patient specific implants (PSI). However, no interventional studies exist in the literature on its application in cranioplasty.

Explanation for choice of comparators:

PEEK as a semicrystalline thermoplastic polymer has a thickness and elasticity comparable to cortical bone making it one of the most commonly used bone substitute materials and is currently recommended as a standard viable option for cranial defects.

Eligibility criteria: Inclusion Criteria:

* Cranial defect patients
* Patients eligible for simultaneous craniectomy and cranioplasty.
* ASA I \& II

Exclusion Criteria:

* Active infection.
* Medically compromised patients (ASA ≥3).
* Hydrocephalus/Brain Swelling

Primary outcomes:
measure: Cosmetic patient satisfaction
timeFrame: 6 months
Secondary outcomes:
measure: Overall complications
timeFrame: 6 months
measure: implant failure
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Nasser Institute Hospital
state: Shubra
Study officials:
affiliation: Cairo University
name: Mamdouh A Sayed, Professor
role: STUDY_DIRECTOR
References: