The Canadian Prospective Pragmatic Perilunate Outcomes Trial
NCT ID: NCT04370626
Last Updated: 2022-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
450 participants
OBSERVATIONAL
2020-09-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Surgical Treatment Versus Non-surgical Treatment of Ulnar Fractures
NCT01123447
Immediate Weight-Bearing Ankle Study
NCT03032653
Pilon Fracture Reduction and Functional Outcome
NCT01316289
Early Weight Bearing for Ankle Fractures
NCT02736370
Unreamed Intramedullary Tibial Nailing in Treatment of Open IIIa Diaphyseal Tibial Fractures in Adults
NCT06280417
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Early surgical management with the restoration of normal carpal anatomy is the gold standard for surgical repair of perilunate injuries. Surgical repair may involve an open reduction of the carpal bones, repair or reconstruction of the ligaments, and internal fixation of the fractures for PLDs and PLFDs. However, there is a huge variability with respect to approach and a lot to be desired with respect to outcomes. Open surgical procedures have been reported to lead to capsular scarring and joint stiffness and further interfere with the tenuous blood supply to the scaphoid and the torn ligaments. Another treatment options, which may aid in healing with reduced stiffness, is a combination of fluoroscopy and wrist arthroscopy which allows for anatomic reduction and fixation of the carpal bones with minimal tissue dissection. Injury variability and a wide array of surgical strategies make it difficult to treat and/or make improvements on specific techniques. Given the varied nature of the injury to this joint and varied outcomes, it is important to categorize the injury characteristics, the subsequent treatment options and the long-term outcomes of different clinical interventions. Many different surgical techniques have been advocated with a variety of reduction and fixation maneuvers, but unfortunately, the literature is sparse. There are disagreements with respect to volar, dorsal or combined surgical approaches. There is no consensus on the value of prophylactic carpal tunnel release. Some surgeons advocate direct ligament repair, while others feel it is unnecessary. A third group advocates for augmentation of the scapholunate ligament with screws or a graft. While most surgeons use smooth k-wires to hold the carpal reduction, there is no agreement on direction, number, size and position of k-wires. Further, there is no agreement on how long these k-wires should be left in place or on any aspect of rehabilitation.
Globally these injuries have been poorly studied and ideal timing for surgical intervention, optimal treatment and rehabilitation are unknown. The investigators hope to establish best-evidence clinical practice guidelines for the treatment of perilunate injuries including recommendations on the timing of reduction, the timing of surgery, best-practice surgical techniques and rehabilitation protocols. The C3PO Trial will represent the single largest prospective dataset ever accrued on perilunate injuries with the support of both Canadian hand and trauma-fellowshipped trained orthopaedic surgeons and corresponding research societies. This project has the potential to create a paradigm shift in the way surgeons think about the perilunate injuries from identification through to prognosis which would be beneficial to all orthopaedic traumatologists managing these patients.
The study has 3 major nested arms. The investigators have designed a national prospective registry intended to capture all perilunate injuries suffered in Canada over a 2 year period. Within this registry, the investigators have an embedded cohort to capture all injuries that present to registered trial centres. These patients will be consented to the cohort and subsequently have extensive perioperative data recorded as well as both short and long-term follow-up (with no modification of treatment). All data collection (i.e. relevant demographics, injury characteristics, surgical and management parameters) will be obtained and managed by a customized REDCap database housed at the trial coordinating centre. The third arm of this trial is a retrospective cohort in which patients previously treated for PLIs will be contacted as asked if they would be willing come back to clinic and be follow for the remaining period of the 10-year study.
Participants, 14 years of age or older, clinically diagnosed with a perilunate injury and willing to adhere to the study protocol will be included for study participation. They must be willing and able to attend all recommended post-operative follow-up visits based on the advice of their surgeon. All participants will complete questionnaires and undergo both clinical and radiographic evaluations. These evaluations will begin at baseline, continue at the first post-operative visit, and the following intervals: 3, 6, 12, 24, 60 and 120 months. Individuals will be excluded if they have cognitive impairment or unable to understand what participation in this study entails, a known alcohol or drug abuser, or anticipated to be non-compliant. The investigators anticipate overall 150 patients entered into the cohort, an additional 150 in the registry arm, and 150 patients identified retrospectively.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Registry Group
Patients who sustain and present with a PLI injury will have two options for participating in the study. This first arm will evaluate clinical presentations, patient demographic, treatment methods and baseline patient-rated and radiographic outcomes. However, no research-related follow up visits will be conducted. Ongoing data from these participants will be collected from chart reviews of clinical follow-ups alone.
No interventions assigned to this group
Prospective Group
Participants who choose to enroll in the prospective arm will experience the same baseline data collection as those in the registry, with the addition of research-related follow up appointments that will allow research staff to measure and assess patient-rated and clinical outcomes, such as questionnaires and range of motion data.
No interventions assigned to this group
Retrospective Group
In this group, a chart review will be conducted to identify previously treated patients with perilunate injuries. Once identified, the patient will be contacted and ask if they are willing to come in for a long-term follow up visit where clinical, patient-rated, and radiographic data will be collected. If patients are unwilling to attend a long-term visit, our analysis will still include data collected from their chart reviews and electronic questionnaires.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
14 Years
120 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alberta
OTHER
University of Calgary
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neil J White, MD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
South Health Campus
Calgary, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Tina Samuel, MBBS
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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. No abstract available.
Stanbury SJ, Elfar JC. Perilunate dislocation and perilunate fracture-dislocation. J Am Acad Orthop Surg. 2011 Sep;19(9):554-62. doi: 10.5435/00124635-201109000-00006.
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.
Kozin SH. Perilunate injuries: diagnosis and treatment. J Am Acad Orthop Surg. 1998 Mar-Apr;6(2):114-20. doi: 10.5435/00124635-199803000-00006.
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. doi: 10.1053/ajem.2001.21306.
Weil WM, Slade JF 3rd, Trumble TE. Open and arthroscopic treatment of perilunate injuries. Clin Orthop Relat Res. 2006 Apr;445:120-32. doi: 10.1097/01.blo.0000205889.11824.03.
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. doi: 10.1016/S0363-5023(05)80179-0.
Adkison JW, Chapman MW. Treatment of acute lunate and perilunate dislocations. Clin Orthop Relat Res. 1982 Apr;(164):199-207.
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. doi: 10.1016/j.jhsa.2007.01.008.
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.
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. doi: 10.1053/jhsu.2000.17868.
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.
Mitchell EC, Tottenham I, Grewal R, Curran MWT, White NJ. The Canadian Prospective Pragmatic Perilunate Outcomes (C3PO) trial; a protocol. BMC Musculoskelet Disord. 2025 Jan 31;26(1):93. doi: 10.1186/s12891-024-08227-x.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REB19-1565
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.