--- title: Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability nct_id: NCT05321186 overall_status: UNKNOWN phase: NA sponsor: Assiut University study_type: INTERVENTIONAL primary_condition: SPINAL Fracture canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05321186.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05321186" ct_last_update_post_date: 2022-04-11 last_seen_at: "2026-05-12T06:18:42.413Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Minimally Invasive Surgical Management of Traumatic Spinopelvic Instability **NCT ID:** [NCT05321186](https://clinicaltrials.gov/study/NCT05321186) ## Key Facts - **Status:** UNKNOWN - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 20 - **Lead Sponsor:** Assiut University - **Conditions:** SPINAL Fracture - **Start Date:** 2022-06-01 - **Completion Date:** 2023-06-01 - **CT.gov Last Update:** 2022-04-11 ## Brief Summary the main aim of this study is to evaluate the results of performing minimally invasive surgical management for cases with traumatic spinopelvic instability and spinopelvic dissociation. This will include using percutaneous pedicle and S2 alar iliac screws, minimally invasive transforaminal lumbar interbody fusion and transtubular posterior decompression. ## Detailed Description Study Procedure: 1. Patient enrollment and pre-operative evaluation: Upon Arrival, the patient will be managed in the emergency department according to the Advanced Trauma Life Support (ATLS) protocol. After achieving the haemodynamic stability, in cases of shock, X-rays (AP and lateral view of the lumbosacral region, inlet and outlet views of the pelvis) and CT scan of the pelvis will be performed. If the fracture pattern fits the inclusion criteria, the patient will be offered to enroll in the study and the patient will be prepared for surgery. 2. Surgery: The surgery will be performed under general anaesthesia and fluoroscopic guidance. The patients will be positioned prone on an open top of a radiolucent table with large bumps under the thighs to accentuate an extension force on the legs which will be the main reduction maneuver in the surgical procedure. Bilateral percutaneous L4 and L5 pedicle screws will be placed under fluoroscopic guidance with Jamshidi needles, and these were will also be used the iliac fixation via percutaneous S2 alar iliac screws. Cases presenting with significant instability, minimally invasive Transforaminal lumbar interbody fusion (MIS-TLIF) will be performed. Additionally, in cases with neurological deficit, posterior decompression will be performed. 3. Follow-up The patient will have four follow up visits (one and half month, 3month, 6month and 1 year) besides the discharge visit, during which the functional outcome scores will be filled out. AP and lateral view pelvis x-rays will be performed every visit. CT scan, AP and lateral scanograms will be only performed on the 1-year visit. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 60 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: Skeletally mature patients presenting with sacral fractures (provided that the fracture line passes below the level of S2) associated with lumbosacral instability showing one of the following: 1. Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2) 2. Spinopelvic dissociation (AO type C3) 3. Traumatic lumbosacral dislocation Exclusion Criteria: 1. unwillingness to participate in the study 2. pathological fractures 3. other medical comorbidities that preclude surgical intervention. ``` ## Arms - **minimally invasive spinopelvic fixation.** (OTHER) — the arm will include skeletally mature patients (between the age of 18-60) presenting with sacral fractures (provided that the fracture line passes below the level of S2) associated with lumbosacral instability) with the following inclusion and exclusion criteria. 1. Inclusion criteria: 1. Unilateral or bilateral L5-S1 facet fractures (AO classification type C1 and C2) 2. Spinopelvic dissociation (AO type C3) 3. Traumatic lumbosacral dislocation 2. Exclusion criteria: 1. unwillingness to participate in the study 2. pathological fractures 3. other medical comorbidities that preclude surgical intervention. ## Interventions - **minimally invasive spinopelvic fixation** (PROCEDURE) — Bilateral percutaneous L4 and L5 pedicle screws will be placed under fluoroscopic guidance with Jamshidi needles, and these were will also be used the iliac fixation via percutaneous S2 alar iliac screws. Cases presenting with significant instability, minimally invasive Transforaminal lumbar interbody fusion (MIS-TLIF) will be performed. Additionally, in cases with neurological deficit, posterior decompression will be performed. ## Primary Outcomes - **Change in the Majeed pelvic score** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ — it is a patient reported outcome score used for functional assessment after pelvic fractures.The score ranges from 0 to 100 with 0 representing the most disability and 100 the best function. ## Secondary Outcomes - **Short Form 12 (SF-12) score** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ - **Oswestry disability index (ODI):** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ - **Visual analogue scale of pain (VAS)** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ - **AO PROST** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ - **lumbar lordosis** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ - **Gibbons' criteria** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ - **pelvic incidence** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ - **AP translation** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ - **vertical translation** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ - **sacral table angle** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ - **sacral kyphosis angle** _(time frame: it will be assessed at one and half month, three month, six month and one year after the surgery)_ ## Recent Field Changes (last 30 days) - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT05321186.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT05321186* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*