NCT04668794

Brief Summary

Fracture-dislocation of the carpometacarpal (CMC) joints of the ring and little finger are the most affected CMC joints and the dislocation may be accompanied by other hand injuries. Fracture-dislocation of the CMC joints of the ring and little finger are extremely mobile because of their saddle shape anatomy and loose ligamentous attachments. Missed and incorrect diagnosis is very frequent in metacarpal base injuries of the hand and results in impaired function and weak grip. In these lesions immediate reduction is imperative. Treatment options for these injuries include non-operative management, closed reduction with Kirschner wire fixation (K-wire) and open reduction with internal fixation (ORIF). In chronic CMC fracture-dislocations ORIF is mandatory. Although operative treatment is recommended in the literature in fracture-dislocation of the CMC joints of the ring and little finger, other authors, in specific cases, performed conservative treatment through immediate reduction and splint immobilization and this treatment can be sufficient.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2022

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

1.9 years

First QC Date

December 9, 2020

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Hamate fracture

    Hamate fracture associated with the dislocation of the fifth and fourth finger. Cain´s classification for the description of fracture-dislocation. Milch´s classification for hamate fractures types.

    6 months

  • Degree of displacement

    Degree of displacement (% displacement) in X-rays and CT scan.

    6 months

  • Intrarticular stepoff and degenerative osteoarthritis

    Intrarticular stepoff (mm) and sclerosis, cysts, osteophytes, joint space reduction (mm) in X-rays and CT scan

    6 months

Interventions

Reduction and fixation of the carpometacarpal fracture dislocation of the hand with osteosynthesis (Kirschners wires, plate and screws)

Also known as: Cast

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients are adults with a closed injury in their hand. For clinical, x-ray and TC we evaluated the carpometacarpal fracture dislocation of the hand and associated lesions.

You may qualify if:

  • Closed carpometacarpal fracture dislocation of the hand
  • Adults from 18 to 80 years old

You may not qualify if:

  • history of fractures or tendon lesions in the same hand
  • Children
  • Open fracture dislocations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (10)

  • Kural C, Basaran SH, Ercin E, Bayrak A, Bilgili MG, Baca E. Fourth and fifth carpometacarpal fracture dislocations. Acta Orthop Traumatol Turc. 2014;48(6):655-60. doi: 10.3944/AOTT.2014.14.0040.

  • Gehrmann SV, Kaufmann RA, Grassmann JP, Logters T, Schadel-Hopfner M, Hakimi M, Windolf J. Fracture-dislocations of the carpometacarpal joints of the ring and little finger. J Hand Surg Eur Vol. 2015 Jan;40(1):84-7. doi: 10.1177/1753193414562706.

  • Mueller JJ. Carpometacarpal dislocations: report of five cases and review of the literature. J Hand Surg Am. 1986 Mar;11(2):184-8. doi: 10.1016/s0363-5023(86)80048-x.

  • Henderson JJ, Arafa MA. Carpometacarpal dislocation. An easily missed diagnosis. J Bone Joint Surg Br. 1987 Mar;69(2):212-4. doi: 10.1302/0301-620X.69B2.3818751.

  • Kjaer-Petersen K, Jurik AG, Petersen LK. Intra-articular fractures at the base of the fifth metacarpal. A clinical and radiographical study of 64 cases. J Hand Surg Br. 1992 Apr;17(2):144-7. doi: 10.1016/0266-7681(92)90075-d.

  • Cobb WA, Dingle L, Zarb Adami R, Rodrigues J. Management of fracture-dislocations of the little finger carpometacarpal joint: a systematic review. J Hand Surg Eur Vol. 2018 Jun;43(5):530-538. doi: 10.1177/1753193417752317. Epub 2018 Feb 7.

  • Storken G, Bogie R, Jansen EJ. Acute ulnar carpometacarpal dislocations. Can it be treated conservatively? A review of four cases. Hand (N Y). 2011 Dec;6(4):420-3. doi: 10.1007/s11552-011-9347-3. Epub 2011 Jul 7. No abstract available.

  • Fisher MR, Rogers LF, Hendrix RW. Systematic approach to identifying fourth and fifth carpometacarpal joint dislocations. AJR Am J Roentgenol. 1983 Feb;140(2):319-24. doi: 10.2214/ajr.140.2.319.

  • Hodgson PD, Shewring DJ. The 'metacarpal cascade lines'; use in the diagnosis of dislocations of the carpometacarpal joints. J Hand Surg Eur Vol. 2007 Jun;32(3):277-81. doi: 10.1016/J.JHSB.2006.09.020.

  • Fa-Binefa M, Almenara M, Mata-Munoz JM, Gich-Saladich I, Llauger J, Lamas C. Retrospective interobserver agreement on diagnoses of 4th and 5th carpometacarpal fracture-dislocation and hamate fracture in plain X-ray - Is CT essential after ulnar carpometacarpal pain? Skeletal Radiol. 2023 Dec;52(12):2427-2433. doi: 10.1007/s00256-023-04366-9. Epub 2023 May 25.

MeSH Terms

Conditions

Joint Dislocations

Interventions

Fracture Fixation, InternalPOLR1G protein, human

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Claudia Lamas, MD, PhD

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 16, 2020

Study Start

November 2, 2020

Primary Completion

October 10, 2022

Study Completion

November 14, 2022

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Retrospective study that observe the x-rays and TC scan and the results of the surgical or conservative treatment.

Locations