German Cranial Reconstruction Registry (GCRR): protocol for a prospective, multicentre, open registry

Abstract

IntroductionOwing to increasing numbers of decompressive craniectomies in patients with malignant middle cerebral artery infarction, cranioplastic surgery becomes more relevant. However, the current literature mainly consists of retrospective single-centre (evidence class III) studies. This leads to a wide variability of technical approaches and clinical outcomes. To improve our knowledge about the key elements of cranioplasty, which may help optimising clinical treatment and long-term outcome, a prospective multicentre registry across Germany, Austria and Switzerland will be established.MethodsAll patients undergoing cranioplastic surgery in participating centres will be invited to join the registry. Technical methods, materials, medical history, adverse events and clinical outcome measures, including modified Rankin scale and EQ-5D, will be assessed at several time points. Patients will be accessible to inclusion either at initial decompressive surgery or when cranioplasty is planned. Scheduled monitoring will be carried out at time of inclusion and subsequently at time of discharge, if any readmission is necessary, and at follow-up presentation. Cosmetic results and patient satisfaction will also be assessed. Collected data will be managed and statistically analysed by an independent biometric institute. The primary endpoint will be mortality, need for operative revision and neurological status at 3 months following cranioplasty.Ethics and disseminationEthics approval was obtained at all participating centres. The registry will provide reliable prospective evidence on surgical techniques, used materials, adverse events and functional outcome, to optimise patient treatment. We expect this study to give new insights in the treatment of skull defects and to provide a basis for future evidence-based therapy regarding cranioplastic surgery.Trial registration numberThis trial is indexed in the German Clinical Trials Register (DRKS-ID: DRKS00007931). The Universal Trial Number (UTN) is U1111-1168-7425.

Decompressive craniectomy for acute ischemic stroke

“…However, when retrieving current entries from the ClinicalTrials.gov database regarding “decompressive craniectomy,” an apparent shift in clinical research focus becomes obvious: current prospective studies analyze the syndrome of the trephined (NCT03186157) and resorption of autologous bone flaps (NCT02320955). Similar prospective studies are also conducted elsewhere, such as the German Cranial Reconstruction Registry (German Clinical Trials Register ID DRKS00007931) [85]. This shift in focus towards cranioplasty will hopefully provide valuable data to optimize treatment in the aftermath of DC.…”

Long-term complications and implant survival rates after cranioplastic surgery: a single-center study of 392 patients

“…The study was a retrospective work, reducing the level of evidence because of the possible presence of uncontrolled confounding factors as well as missing or biased data. Further studies (preferably RCTs) are necessary to prospectively analyze the modalities of autologous and alloplastic CP surgery with regard to complication rates and possible influencing factors as well as neurological outcome [ 4 ].…”

Long-Term Results of Neurological Outcome, Quality of Life, and Cosmetic Outcome After Cranioplastic Surgery: A Single Center Study of 202 Patients

“…Further studies (RCTs, registries) are necessary to prospectively analyze a pre- and post-operative as well as long-term outcome and QoL after DC/CP surgery. Two registry studies on CP have already been initiated in Europe, nevertheless results are still pending ( 32 , 33 ).…”