The Clinical and Radiological Outcomes of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

NCT05315284 | Unknown

• 1 other identifier: Soh-Med-22-02-08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The Clinical and Radiological Outcomes of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

Conditions

Fracture Clavicle

Outcome Measures

Primary Outcomes (2)

• The Clinical Outcome of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

  Investigating the union rate and complications rate following titanium elastic stable intramedullary nailing (ESIN) clinically for midshaft non-comminuted clavicle fractures with \>20 mm shortening/displacement.

  3 months

• The Radiological Outcome of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

  Investigating the union rate and complications rate following titanium elastic stable intramedullary nailing (ESIN) radiologically for midshaft non-comminuted clavicle fractures with \>20 mm shortening/displacement.

  3 months

Study Arms (1)

Patients with fresh non-comminuted fracture mid-shaft clavicle

OTHER

Procedure: the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

Interventions

the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle PROCEDURE

Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

Patients with fresh non-comminuted fracture mid-shaft clavicle

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• : (1) Type IIA2 (angulation \> 45 ) or IIB1 (shortening or overlapping displacement length \> 2 cm) fresh unilateral midshaft clavicular fractures according to Robinson classification. (2) Patient without underlying diseases such as primary hypertension and cardiac diseases.

You may not qualify if:

• (1) pathological fractures. (2) multiple injuries of upper limbs. (3) open fractures. (4) combined with injuries of blood vessels or nerves. (5) other diseases which affected the functions of upper limbs. (6) Proximal and distal clavicular fractures. (7) Comminuted clavicular fractures.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, 82511, Egypt

RECRUITING

Related Publications (1)

• 1. Duan X, Zhong G, Cen S, Huang F, Xiang Z. Plating versus intramedullary pin or conservative treatment for midshaft fracture of clavicle: A meta-analysis of randomized controlled trials. J Shoulder Elbow Surg 2011;20:1008-15. 2. Schiffer G, Faymonville C, Skouras E, Andermahr J, Jubel A. Midclavicular fracture: not just a trivial injury: Current treatment options. Dtsch Arztebl Int 2010;107:711-7. 3. Neer CS 2nd. Nonunion of the clavicle. J Am Med Assoc 1960;172:1006-11. 4. Rowe CR. An atlas of anatomy and treatment of midclavicular fractures. Clin Orthop Relat Res 1968;58:29-42. 5. Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br 1997;79:537-9. 6. McKee MD, Pedersen EM, Jones C, Stephen DJ, Kreder HJ, Schemitsch EH. Deficits following nonoperative treatment of displaced midshaft clavicular fractures. J Bone Joint Surg Am 2006;88:35-40. 7. Smekal V, Irenberger A, Struve P, Wambacher M, Krappinger D, Kralinger FS. Elastic stable intramedullary nailing versus nonoperative treatment of displaced midshaft clavicular fractures-a randomized, controlled, clinical trial. J Orthop Trauma 2009;23:106-12. 8. Frigg A, Rillmann P, Perren T, Gerber M, Ryf C. Intramedullary nailing of clavicular midshaft fractures with the titanium elastic nail: Problems and complications. Am J Sports Med 2009;37:352-9. 9. Khalil A. Intramedullary screw fixation for midshaft fractures of the clavicle. Int Orthop 2009;33:1421-4. 10. Peroni L. Medullary osteosynthesis in the treatment of clavicle fractures. Arch Ortop 1950;63:398-405. 11. Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD, EvidenceBased Orthopaedic Trauma Working G. Treatment of acute midshaft clavicle fractures: Systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma 2005;19:504-7. 12. Millett PJ, Hurst JM, Horan MP, Hawkins RJ. Complications of clavicle fractures treated with intramedullary fixation. J Shoulder Elbow Surg 2011;20:86-91. 13. Mueller M, Rangger C, Striepens N, Burger C. Minimally invasive intramedullary nailing of midshaft clavicular fractures using titanium elastic nails. J Trauma 2008;64:1528-34. 14. Dawson J, Hill G, Fitzpatrick R, Carr A. The benefits of using patient-based methods of assessment. Medium-term results of an observational study of shoulder surgery. J Bone Joint Surg Br 2001;83:877-82. 15. Beaton DE, Wright JG, Katz JN, Upper Extremity Collaborative G. Development of the QuickDASH: Comparison of three itemreduction approaches. J Bone Joint Surg Am 2005;87:1038-46. 16. Canadian Orthopaedic Trauma S. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am 2007;89:1-10. 17. Mullaji AB, Jupiter JB. Low-contact dynamic compression plating of the clavicle. Injury 1994;25:41-5. 18. Schuind F, Pay-Pay E, Andrianne Y, Donkerwolcke M, Rasquin C, Burny F. External fixation of the clavicle for fracture or nonunion in adults. J Bone Joint Surg Am 1988;70:692-5. 19. Ferran NA, Hodgson P, Vannet N, Williams R, Evans RO. Locked intramedullary fixation vs plating for displaced and shortened mid-shaft clavicle fractures: A randomized clinical trial. J Shoulder Elbow Surg 2010;19:783-9. 20. Kleweno CP, Jawa A, Wells JH, O'Brien TG, Higgins LD, Harris MB. Midshaft clavicular fractures: Comparison of intramedullary pin and plate fixation. J Shoulder Elbow Surg 2011;20:1114-7. 21. Liu HH, Chang CH, Chia WT, Chen CH, Tarng YW, Wong CY. Comparison of plates versus intramedullary nails for fixation of displaced midshaft clavicular fractures. J Trauma 2010;69:E82-7. 22. Smekal V, Irenberger A, Attal RE, Oberladstaetter J, Krappinger D, Kralinger F. Elastic stable intramedullary nailing is best for midshaft clavicular fractures without comminution: Results in 60 patients. Injury 2011;42:324-9. 23. Jubel A, Andemahr J, Bergmann H, Prokop A, Rehm KE. Elastic stable intramedullary nailing of midclavicular fractures in athletes. Br J Sports Med 2003;37:480-3; discussion 4. 24. Chen YF, Wei HF, Zhang C, Zeng BF, Zhang CQ, Xue JF. Retrospective comparison of titanium elastic nail (TEN) and reconstruction plate repair of displaced midshaft clavicular fractures. J Shoulder Elbow Surg 2012;21:495-501. 25. Smekal V, Oberladstaetter J, Struve P, Krappinger D. Shaft fractures of the clavicle: Current concepts. Arch Orthop Trauma Surg 2009;129:807-15.

  RESULT

Central Study Contacts

Mostafa Salah, Bachelor of Medicine, Bachelor

CONTACT

01002397597; doc.mostafasala7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 7, 2022
• Study Start: December 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)