Robot Assisted Minimally Invasive Treatment Versus Conservative Treatment for Fragility Fractures of the Pelvis Type 1-2 in Elderly Patients (FFP)
Comparing the Efficacy and Safety of Robot Assisted Minimally Invasive Treatment Versus Conservative Treatment in Elderly Patients With FFP1-2 Fragility Fractures of the Pelvis
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This study is a prospective, single center, stratified randomized controlled trial designed to compare the efficacy and safety of robot assisted minimally invasive treatment versus conservative treatment in elderly patients with FFP1-2 fragility fractures of the pelvis.
A total of 152 patients will be enrolled and randomly assigned in a 1:1 ratio to either the robot assisted minimally invasive treatment group or the conservative treatment group. Randomization will be stratified according to FFP classification (FFP1 or FFP2) using a computer generated randomization sequence.
Eligible participants include patients aged 60 years or older diagnosed with osteoporosis related FFP1 or FFP2 pelvic fragility fractures caused by low energy trauma. The primary objective is to compare pain control, early weight bearing, functional recovery, fracture progression, venous thromboembolism events, and healthcare resource utilization between treatment strategies.
Patients in the robot assisted treatment group will undergo robot assisted minimally invasive pelvic fixation, while patients in the conservative treatment group will receive standardized nonoperative management including pain control, anticoagulation prophylaxis, rehabilitation, and osteoporosis treatment.
Outcome measures include pain scores, Majeed pelvic function score, EQ 5D, SMFA, imaging evaluation of fracture progression and healing, venous thromboembolism events, laboratory parameters, muscle mass changes, bone mineral density, opioid consumption, complications, and healthcare costs. Follow up assessments will be performed at postoperative day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year.
The results of this study may provide evidence regarding the optimal treatment strategy for elderly patients with FFP1-2 pelvic fragility fractures.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Junbo Liang
- Telefonní číslo: 0576-85190463
- E-mail: liangjb@enzemed.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Age ≥ 60 years Low energy trauma Diagnosis of osteoporosis Diagnosis of FFP1 or FFP2 fragility fractures of the pelvis Injury duration less than 3 weeks Ability to walk independently or with assistance before injury Ability to provide written informed consent
Exclusion Criteria:
Severe open injury or skin infection at the surgical site Long term bedridden status or severe disability Severe psychiatric disorders or dementia Severe obesity affecting imaging quality Severe systemic diseases preventing surgery Pathological fracture Current chemotherapy, radiotherapy, systemic corticosteroid therapy, or growth factor therapy
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Robot Assisted Minimally Invasive Treatment Group
Participants undergo robot assisted minimally invasive fixation for FFP1-2 fragility fractures of the pelvis.
|
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of pelvic fragility fractures.
|
|
Aktivní komparátor: Conservative Treatment Group
Participants receive standardized conservative treatment including pain management, rehabilitation, anticoagulation prophylaxis, and osteoporosis treatment.
|
Robot assisted minimally invasive fixation is performed using robotic navigation assisted percutaneous screw placement for stabilization of pelvic fragility fractures.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Visual Analog Scale (VAS) for Pain
Časové okno: At day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Visual Analog Scale (VAS) for pain.
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse pain severity.
|
At day 1, day 2, day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
Majeed Pelvic Function Score
Časové okno: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
EuroQol 5-Dimension 3-Level Questionnaire
Časové okno: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
|
Short Musculoskeletal Function Assessment (SMFA)
Časové okno: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
|
Fracture Progression and Healing
Časové okno: At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Assessment of fracture healing, secondary displacement, and FFP classification progression using pelvic CT.
|
At day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
complication
Časové okno: From treatment initiation to 1 year follow up
|
Assessment of complication events during follow up.
|
From treatment initiation to 1 year follow up
|
|
Opioid Consumption
Časové okno: Days 0-3 after treatment
|
Assessment of cumulative opioid consumption during hospitalization
|
Days 0-3 after treatment
|
|
Serum C-Reactive Protein Level
Časové okno: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
|
D-Dimer Level
Časové okno: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
|
|
Hemoglobin Level
Časové okno: Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Preoperatively and at day 3, 2 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after treatment
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Obecné publikace
- Zong Y, Li J, Li Z, Wang W. Minimally invasive surgery and conservative treatment achieve similar clinical outcomes in patients with type II fragility fractures of the pelvis. J Orthop Surg Res. 2025 Feb 27;20(1):210. doi: 10.1186/s13018-025-05581-x.
- Haentjens P, Magaziner J, Colon-Emeric CS, Vanderschueren D, Milisen K, Velkeniers B, Boonen S. Meta-analysis: excess mortality after hip fracture among older women and men. Ann Intern Med. 2010 Mar 16;152(6):380-90. doi: 10.7326/0003-4819-152-6-201003160-00008.
- Banierink H, Ten Duis K, de Vries R, Wendt K, Heineman E, Reininga I, IJpma F. Pelvic ring injury in the elderly: Fragile patients with substantial mortality rates and long-term physical impairment. PLoS One. 2019 May 28;14(5):e0216809. doi: 10.1371/journal.pone.0216809. eCollection 2019.
- Yamamoto N, Someko H, Nakashima Y, Nakao S, Kaneko T, Tsuge T. Mortality following fragility fractures of the pelvis: Systematic review and meta-analysis. Injury. 2025 Oct;56(10):112618. doi: 10.1016/j.injury.2025.112618. Epub 2025 Jul 21.
- Nakayama Y, Suzuki T, Kurozumi T, Watanabe Y. Progression to Rommens type IIIa fragility fracture of the pelvis managed by delayed open reduction and interdigitating screw fixation: A case report. Trauma Case Rep. 2023 Jan 13;43:100773. doi: 10.1016/j.tcr.2023.100773. eCollection 2023 Feb.
- Rommens PM, Arand C, Hopf JC, Mehling I, Dietz SO, Wagner D. Progress of instability in fragility fractures of the pelvis: An observational study. Injury. 2019 Nov;50(11):1966-1973. doi: 10.1016/j.injury.2019.08.038. Epub 2019 Aug 27.
- Jiang Y, Qi X, Cui H, Huang Y, Lv Y, Yang Y, Yao X, Yang D. The Inflammation-Energy Metabolism Axis: A Central Driver of Sarcopenia-Osteoporosis: A Narrative Review. Calcif Tissue Int. 2026 Jan 7;117(1):9. doi: 10.1007/s00223-025-01473-8.
- Lin YH, Shih YT, Teng MMH. The Impact of the "Osteo" Component of Osteosarcopenia on Fragility Fractures in Post-Menopausal Women. Int J Mol Sci. 2021 May 17;22(10):5256. doi: 10.3390/ijms22105256.
- Meermans G, van Egmond JC. Malnutrition in Older Hip Fracture Patients: Prevalence, Pathophysiology, Clinical Outcomes, and Treatment-A Systematic Review. J Clin Med. 2025 Aug 11;14(16):5662. doi: 10.3390/jcm14165662.
- Rommens PM, Arand C, Hofmann A, Wagner D. When and How to Operate Fragility Fractures of the Pelvis? Indian J Orthop. 2019 Jan-Feb;53(1):128-137. doi: 10.4103/ortho.IJOrtho_631_17.
- Ali KA, He L, Li W, Zhang W, Huang H. Sleep quality and psychological health in patients with pelvic and acetabulum fractures: a cross-sectional study. BMC Geriatr. 2024 Apr 4;24(1):314. doi: 10.1186/s12877-024-04929-y.
- Hutchings L, Roffey DM, Lefaivre KA. Fragility Fractures of the Pelvis: Current Practices and Future Directions. Curr Osteoporos Rep. 2022 Dec;20(6):469-477. doi: 10.1007/s11914-022-00760-9. Epub 2022 Nov 7.
- GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- K20260153
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .