Trauma Clinical Trial
— C3POOfficial title:
The Canadian Prospective Pragmatic Perilunate Outcomes Trial (The C3PO Trial)
This is a unique three-fold prospective and retrospective study. With this approach, all previous and current PLIs presented at participating study sites will have the potential to be included in the study. Our goal is to collect all relevant injury and surgical parameters of the Perilunate spectrum. The investigators plan to identify each hospital within Canada that normally treats PLIs and to record injury and demographic information on each PLI that occurs in this country over a two to three-year period. Our protocol includes scheduled two, five, and 10-year follow-up intervals.
Status | Recruiting |
Enrollment | 450 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 120 Years |
Eligibility | Inclusion Criteria: - The subject is 14 years of age or older - The subject has been clinically diagnosed with a perilunate injury - The subject is willing to adhere to the study protocol including required post-operative therapy, all scheduled follow-up visits, evaluations, and questionnaires (if applicable). Exclusion Criteria: There will be no limiting exclusion criteria. |
Country | Name | City | State |
---|---|---|---|
Canada | South Health Campus | Calgary | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Calgary | University of Alberta |
Canada,
Adkison JW, Chapman MW. Treatment of acute lunate and perilunate dislocations. Clin Orthop Relat Res. 1982 Apr;(164):199-207. — View Citation
Capo JT, Corti SJ, Shamian B, Nourbakhsh A, Tan V, Kaushal N, Debkowska M. Treatment of dorsal perilunate dislocations and fracture-dislocations using a standardized protocol. Hand (N Y). 2012 Dec;7(4):380-7. doi: 10.1007/s11552-012-9452-y. — View Citation
Garg B, Goyal T, Kotwal PP. Triple jeopardy: transscaphoid, transcapitate, transtriquetral, perilunate fracture dislocation. J Orthop Traumatol. 2013 Sep;14(3):223-6. doi: 10.1007/s10195-012-0195-x. Epub 2012 Apr 4. — View Citation
Hildebrand KA, Ross DC, Patterson SD, Roth JH, MacDermid JC, King GJ. Dorsal perilunate dislocations and fracture-dislocations: questionnaire, clinical, and radiographic evaluation. J Hand Surg Am. 2000 Nov;25(6):1069-79. — View Citation
Kozin SH. Perilunate injuries: diagnosis and treatment. J Am Acad Orthop Surg. 1998 Mar-Apr;6(2):114-20. Review. — View Citation
Krief E, Appy-Fedida B, Rotari V, David E, Mertl P, Maes-Clavier C. Results of Perilunate Dislocations and Perilunate Fracture Dislocations With a Minimum 15-Year Follow-Up. J Hand Surg Am. 2015 Nov;40(11):2191-7. doi: 10.1016/j.jhsa.2015.07.016. Epub 2015 Aug 29. — View Citation
Massoud AH, Naam NH. Functional outcome of open reduction of chronic perilunate injuries. J Hand Surg Am. 2012 Sep;37(9):1852-60. doi: 10.1016/j.jhsa.2012.06.009. Epub 2012 Jul 31. — View Citation
Muppavarapu RC, Capo JT. Perilunate Dislocations and Fracture Dislocations. Hand Clin. 2015 Aug;31(3):399-408. doi: 10.1016/j.hcl.2015.04.002. Review. — View Citation
Perron AD, Brady WJ, Keats TE, Hersh RE. Orthopedic pitfalls in the ED: lunate and perilunate injuries. Am J Emerg Med. 2001 Mar;19(2):157-62. Review. — View Citation
Sotereanos DG, Mitsionis GJ, Giannakopoulos PN, Tomaino MM, Herndon JH. Perilunate dislocation and fracture dislocation: a critical analysis of the volar-dorsal approach. J Hand Surg Am. 1997 Jan;22(1):49-56. — View Citation
Souer JS, Rutgers M, Andermahr J, Jupiter JB, Ring D. Perilunate fracture-dislocations of the wrist: comparison of temporary screw versus K-wire fixation. J Hand Surg Am. 2007 Mar;32(3):318-25. — View Citation
Stanbury SJ, Elfar JC. Perilunate dislocation and perilunate fracture-dislocation. J Am Acad Orthop Surg. 2011 Sep;19(9):554-62. Review. — View Citation
Vitale MA, Seetharaman M, Ruchelsman DE. Perilunate dislocations. J Hand Surg Am. 2015 Feb;40(2):358-62; quiz 362. doi: 10.1016/j.jhsa.2014.10.006. Epub 2014 Nov 15. — View Citation
Weil WM, Slade JF 3rd, Trumble TE. Open and arthroscopic treatment of perilunate injuries. Clin Orthop Relat Res. 2006 Apr;445:120-32. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disabilities of the Arm, Shoulder and Hand (DASH) | The upper extremity scoring scale DASH is a validated tool for disorders of the elbow with a range from 0 (least disability) to 100 (most disability). Ten is the average score in the general population and the minimal clinically important difference (MCID) is 10. DASH contains 30 questions asking participants about their ability to perform activities and their symptoms. Each question ranges from 1 (no difficulty) to 5 (unable). There is also optional work and sports/performing arts modules. | Enrollment - 10 years | |
Secondary | Radiographs | Radiographic evaluation for fracture healing and/or nonunion, and the number of participants requiring re-operation for contracture and also composite re-operation for all perilunate fractures and/or dislocations related causes. This will be completed by a radiologist. | Enrollment - 10 years |
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