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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04668794
Other study ID # IIBSP-FLC-2020-29
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2, 2020
Est. completion date November 14, 2022

Study information

Verified date March 2023
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Physical examination in carpometacarpal injuries reveals ulnar-sided pain, swelling, diffuse edema, a palpable lump and tenderness of the hand. Radiological examination include hand-wrist radiographs in the posteroanterior (PA), true lateral and 45º oblique views. A true lateral view of the hand may demonstrate the dislocation, although overlapping of the joints can mask the dislocation. On PA radiographs, Fisher et al. propose using the so-called M-line parallelism of the CMC joints. A break in this M-line suggests a dislocation. Another method is to draw metacarpal cascade lines on a PA radiographs. It is important to recognise the associate lesions, for example hamate fractures, because this fracture can change the prognosis, surgical planning and treatment. The investigators hypothesized that there is an interobserver variability to evaluate the carpometacarpal fracture-dislocation and associated lesions in x-rays are underestimated. The investigators propose a protocol with a CT scan to asses this lesions. The researchers hypothesised that surgical reconstruction would result in better clinical result and lower complications rate than non-surgical treatment.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 14, 2022
Est. primary completion date October 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Closed carpometacarpal fracture dislocation of the hand - Adults from 18 to 80 years old Exclusion Criteria: - history of fractures or tendon lesions in the same hand - Children - Open fracture dislocations

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Degree of displacement Degree of displacement (% displacement) in X-rays and CT scan. 6 months
Primary Intrarticular stepoff and degenerative osteoarthritis Intrarticular stepoff (mm) and sclerosis, cysts, osteophytes, joint space reduction (mm) in X-rays and CT scan 6 months