Pectoralis Major Pedicle Bone Graft For 4-Part Proximal Humerus Fractures
30. juli 2021 oppdatert av: Bulent KARSLIOGLU, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
The investigators tried to evaluate the results of our patients who underwent plate osteosynthesis with vascularized pectoralis major graft for the treatment of 4-part proximal humerus fractures.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
The risk of avascular necrosis, nonunion, or malunion is high in 4-part fractures which is the most serious form of proximal humerus fracture.Bone impaction grafts are an important treatment option when osteosynthesis with LCP plate is desired especially for osteoporotic patients.
Fibular strut grafts (FSGs) and autologous iliac bone impaction grafts (AIBIGs), which are frequently used to provide mechanical support, may have the risk of nonunion in osteoporotic bone whose vascular support is weakened due to fracture.
Bone pedicled pectoralis major grafts may prevent varus collapse, nonunion and avascular necrosis.
Studietype
Intervensjonell
Registrering (Faktiske)
17
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Istanbul, Tyrkia, 34040
- SBU Prof. Cemil Tascioglu City Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- patients aged 50-75 years with closed Neer type 4 proximal humerus fractures
Exclusion Criteria:
- Patients under 50 and over 75 years of age,
- Patients with pathological fractures,
- Patients with neurological deficits such as brachial plexus injury
- Patients with previous shoulder surgery
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Patients with closed Neer type 4 proximal humerus fractures
patients aged 50-75 years with closed Neer type 4 proximal humerus fractures
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It is aimed to restore the integrity of the medial cortex with the bone pedicle from the insertion region of the pectoralis major muscle in middle-aged patients with Neer type 4 proximal humerus fractures.
Researchers aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method.
The investigators aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Patients were evaluated in terms of functional shoulder results and radiographic union
Tidsramme: 2 years
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Constant and American shoulder and elbow surgeons scores were used for functional assesment
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2 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Palvanen M, Kannus P, Niemi S, Parkkari J. Update in the epidemiology of proximal humeral fractures. Clin Orthop Relat Res. 2006 Jan;442:87-92. doi: 10.1097/01.blo.0000194672.79634.78.
- Neer CS 2nd. Displaced proximal humeral fractures. I. Classification and evaluation. J Bone Joint Surg Am. 1970 Sep;52(6):1077-89. No abstract available.
- Fialka C, Stampfl P, Arbes S, Reuter P, Oberleitner G, Vecsei V. Primary hemiarthroplasty in four-part fractures of the proximal humerus: randomized trial of two different implant systems. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):210-5. doi: 10.1016/j.jse.2007.07.002. Epub 2007 Oct 10.
- Kim SH, Lee YH, Chung SW, Shin SH, Jang WY, Gong HS, Baek GH. Outcomes for four-part proximal humerus fractures treated with a locking compression plate and an autologous iliac bone impaction graft. Injury. 2012 Oct;43(10):1724-31. doi: 10.1016/j.injury.2012.06.029. Epub 2012 Jul 20.
- Konrad G, Bayer J, Hepp P, Voigt C, Oestern H, Kaab M, Luo C, Plecko M, Wendt K, Kostler W, Sudkamp N. Open reduction and internal fixation of proximal humeral fractures with use of the locking proximal humerus plate. Surgical technique. J Bone Joint Surg Am. 2010 Mar;92 Suppl 1 Pt 1:85-95. doi: 10.2106/JBJS.I.01462.
- Clavert P, Adam P, Bevort A, Bonnomet F, Kempf JF. Pitfalls and complications with locking plate for proximal humerus fracture. J Shoulder Elbow Surg. 2010 Jun;19(4):489-94. doi: 10.1016/j.jse.2009.09.005. Epub 2009 Dec 7.
- Gallo RA, Sciulli R, Daffner RH, Altman DT, Altman GT. Defining the relationship between rotator cuff injury and proximal humerus fractures. Clin Orthop Relat Res. 2007 May;458:70-7. doi: 10.1097/BLO.0b013e31803bb400.
- Choo A, Sobol G, Maltenfort M, Getz C, Abboud J. Prevalence of rotator cuff tears in operative proximal humerus fractures. Orthopedics. 2014 Nov;37(11):e968-74. doi: 10.3928/01477447-20141023-52.
- Kim SH, Szabo RM, Marder RA. Epidemiology of humerus fractures in the United States: nationwide emergency department sample, 2008. Arthritis Care Res (Hoboken). 2012 Mar;64(3):407-14. doi: 10.1002/acr.21563.
- Adeyemo A, Bertha N, Perry KJ, Updegrove G. Implant Selection for Proximal Humerus Fractures. Orthop Clin North Am. 2021 Apr;52(2):167-175. doi: 10.1016/j.ocl.2020.12.008. Epub 2021 Feb 10.
- Hardeman F, Bollars P, Donnelly M, Bellemans J, Nijs S. Predictive factors for functional outcome and failure in angular stable osteosynthesis of the proximal humerus. Injury. 2012 Feb;43(2):153-8. doi: 10.1016/j.injury.2011.04.003. Epub 2011 May 12.
- Laflamme GY, Moisan P, Chapleau J, Goulet J, Leduc S, Benoit B, Rouleau DM. Novel Technical Factors Affecting Proximal Humerus Fixation Stability. J Orthop Trauma. 2021 May 1;35(5):259-264. doi: 10.1097/BOT.0000000000001984.
- Voigt C, Kreienborg S, Megatli O, Schulz AP, Lill H, Hurschler C. How does a varus deformity of the humeral head affect elevation forces and shoulder function? A biomechanical study with human shoulder specimens. J Orthop Trauma. 2011 Jul;25(7):399-405. doi: 10.1097/BOT.0b013e31820beb80.
- Krappinger D, Bizzotto N, Riedmann S, Kammerlander C, Hengg C, Kralinger FS. Predicting failure after surgical fixation of proximal humerus fractures. Injury. 2011 Nov;42(11):1283-8. doi: 10.1016/j.injury.2011.01.017. Epub 2011 Feb 9.
- Katthagen JC, Schwarze M, Meyer-Kobbe J, Voigt C, Hurschler C, Lill H. Biomechanical effects of calcar screws and bone block augmentation on medial support in locked plating of proximal humeral fractures. Clin Biomech (Bristol, Avon). 2014 Aug;29(7):735-41. doi: 10.1016/j.clinbiomech.2014.06.008. Epub 2014 Jun 19.
- Kim YK, Kang SW, Jung KH, Oh YK. The potential of locking plate with intramedullary fibular allograft to manage proximal humeral fracture with an unstable medial column. Arch Orthop Trauma Surg. 2022 Jan;142(1):91-97. doi: 10.1007/s00402-020-03604-2. Epub 2020 Sep 18.
- Gardner MJ, Weil Y, Barker JU, Kelly BT, Helfet DL, Lorich DG. The importance of medial support in locked plating of proximal humerus fractures. J Orthop Trauma. 2007 Mar;21(3):185-91. doi: 10.1097/BOT.0b013e3180333094.
- McMillan TE, Johnstone AJ. Primary screw perforation or subsequent screw cut-out following proximal humerus fracture fixation using locking plates: a review of causative factors and proposed solutions. Int Orthop. 2018 Aug;42(8):1935-1942. doi: 10.1007/s00264-017-3652-6. Epub 2017 Oct 7.
- Schnetzke M, Bockmeyer J, Loew M, Studier-Fischer S, Grutzner PA, Guehring T. Rate of avascular necrosis after fracture dislocations of the proximal humerus: Timing of surgery. Obere Extrem. 2018;13(4):273-278. doi: 10.1007/s11678-018-0452-6. Epub 2018 Mar 7.
- Neviaser AS, Hettrich CM, Dines JS, Lorich DG. Rate of avascular necrosis following proximal humerus fractures treated with a lateral locking plate and endosteal implant. Arch Orthop Trauma Surg. 2011 Dec;131(12):1617-22. doi: 10.1007/s00402-011-1366-6. Epub 2011 Aug 4.
- Peng C-H, Wu W-T, Yu T-C, Chen L-C, Hsu S-H, Kwong S-T, et al. Surgical treatment for proximal humeral fracture in elderly patients with emphasis on the use of intramedullary strut allografts. Tzu Chi Medical Journal 2012;24:131-5.
- Chen H, Ji X, Zhang Q, Liang X, Tang P. Clinical outcomes of allograft with locking compression plates for elderly four-part proximal humerus fractures. J Orthop Surg Res. 2015 Jul 22;10:114. doi: 10.1186/s13018-015-0258-9.
- Reilly P, Macleod I, Macfarlane R, Windley J, Emery RJ. Dead men and radiologists don't lie: a review of cadaveric and radiological studies of rotator cuff tear prevalence. Ann R Coll Surg Engl. 2006 Mar;88(2):116-21. doi: 10.1308/003588406X94968.
- Fung L, Wong B, Ravichandiran K, Agur A, Rindlisbacher T, Elmaraghy A. Three-dimensional study of pectoralis major muscle and tendon architecture. Clin Anat. 2009 May;22(4):500-8. doi: 10.1002/ca.20784.
- Bois AJ, Lo IKY. Surgical anatomy of the pectoralis major tendon insertion revisited: relationship to nearby structures and the pectoral eminence for defining the anatomic footprint. JSES Int. 2020 May 7;4(2):324-332. doi: 10.1016/j.jseint.2020.02.010. eCollection 2020 Jun.
- Meier JK, Spoerl S, Spanier G, Wunschel M, Gottsauner MJ, Schuderer J, Reichert TE, Ettl T. Alternatives to free flap surgery for maxillofacial reconstruction: focus on the submental island flap and the pectoralis major myocutaneous flap. BMC Oral Health. 2021 Apr 19;21(1):198. doi: 10.1186/s12903-021-01563-7.
- Wyckman A, Abdelrahman I, Steinvall I, Zdolsek J, Granfeldt H, Sjoberg F, Nettelblad H, Elmasry M. Reconstruction of sternal defects after sternotomy with postoperative osteomyelitis, using a unilateral pectoralis major advancement muscle flap. Sci Rep. 2020 May 20;10(1):8380. doi: 10.1038/s41598-020-65398-y.
- Aydin N, Tutuncu MN, Sekizkardes M. Pectoralis major tendon transfer for subscapularis deficiency following multiple failed instability surgeries: A case report. Acta Orthop Traumatol Turc. 2020 Nov;54(6):651-654. doi: 10.5152/j.aott.2020.19174.
- Resch H, Povacz P, Maurer H, Koller H, Tauber M. Pectoralis major inverse plasty for functional reconstruction in patients with anterolateral deltoid deficiency. J Bone Joint Surg Br. 2008 Jun;90(6):757-63. doi: 10.1302/0301-620X.90B6.19804.
- Freeman JL, Walker EP, Wilson JS, Shaw HJ. The vascular anatomy of the pectoralis major myocutaneous flap. Br J Plast Surg. 1981 Jan;34(1):3-10. doi: 10.1016/0007-1226(81)90086-2.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. januar 2017
Primær fullføring (Faktiske)
30. januar 2020
Studiet fullført (Faktiske)
1. februar 2020
Datoer for studieregistrering
Først innsendt
30. juli 2021
Først innsendt som oppfylte QC-kriteriene
30. juli 2021
Først lagt ut (Faktiske)
9. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. august 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. juli 2021
Sist bekreftet
1. juli 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pectoralis Major Pedicle Graft
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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