The Canadian Prospective Pragmatic Perilunate Outcomes Trial

NCT04370626 | Recruiting DMC

• 1 other identifier: REB19-1565
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wrist Injuries; Carpal Bone Fracture; Dislocation of Wrist; Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Radiographs

  Enrollment - 10 years

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Age: 14 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who sustain a perilunate spectrum injury including dislocation and/or fracture.

You may qualify if:

• 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).

Sponsors & Collaborators

• University of Calgary: lead
• University of Alberta: collaborator

Study Sites (1)

South Health Campus

Calgary, Alberta, T3M1M4, Canada

RECRUITING

Related Publications (15)

• 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.

  PMID: 22476357 BACKGROUND

• 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.

  PMID: 22854256 BACKGROUND

• 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.

  PMID: 25459380 BACKGROUND

• 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.

  PMID: 21885701 BACKGROUND

• 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.

  PMID: 24294157 BACKGROUND

• 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.

  PMID: 9682074 BACKGROUND

• 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.

  PMID: 11239263 BACKGROUND

• 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.

  PMID: 16601413 BACKGROUND

• 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.

  PMID: 9018612 BACKGROUND

• Adkison JW, Chapman MW. Treatment of acute lunate and perilunate dislocations. Clin Orthop Relat Res. 1982 Apr;(164):199-207.

  PMID: 7067286 BACKGROUND

• 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.

  PMID: 17336837 BACKGROUND

• 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.

  PMID: 26205701 BACKGROUND

• 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.

  PMID: 11119665 BACKGROUND

• 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.

  PMID: 26328900 BACKGROUND

• 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.

  PMID: 39891160 DERIVED

MeSH Terms

Conditions

Wrist Injuries; Wrist Fractures; Wounds and Injuries

Condition Hierarchy (Ancestors)

Arm Injuries; Fractures, Bone

Study Officials

• Neil J White, MD, FRCSC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adina Tarcea, BMSc

CONTACT

4039563687; adina.tarcea@ucalgary.ca

Sarah L Reitzel, BN

CONTACT

403-956-1971; slreitze@ucalgary.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: May 1, 2020
• Study Start: September 1, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

CA (1)