Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers.

NCT ID: NCT02916940

Last Updated: 2020-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-16

Study Completion Date

2020-02-11

Brief Summary

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There is currently no real consensus on the optimal management of acute sprains of the proximal interphalangeal joint of the long fingers.

The aim of this study is to assess the beneficial effect of an injection of corticosteroids for the treatment of this type of sprain (one single sub-cutaneous injection, in the acute phase). This treatment, if effective, might become the treatment of choice for these types of injuries, instead of a prolonged immobilization or a careful early mobilization.

Detailed Description

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Conditions

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Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diprophos

Patients having had a sprain of the long fingers, within 2 weeks of consultation. This group will receive a single injection of corticoids.

Group Type EXPERIMENTAL

Diprophos

Intervention Type DRUG

Single subcutaneous injection of Diprophos, in the acute phase.

Control group

Patients having had a sprain of the long fingers (Eaton classification type I and II), within 2 weeks of consultation. This group will receive the standard of care treatment, without injection of corticoids.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diprophos

Single subcutaneous injection of Diprophos, in the acute phase.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults over 18 years old
* Type I and II and III of the Eaton classification (except if fracture/luxation with more than 50% of the articular surface injured)
* Trauma of one articulation only
* Consultation within 2 weeks of trauma

Exclusion Criteria

* Patients under 18 years old and over 80 years old
* Pregnant/nursing women
* Eaton classification Type II with a fracture affecting more than 50% of the articular surface, or persistant instability after reduction.
* Open wounds, nerve lesion with sensitive issue and any wound needing a surgical intervention
* Underlying pathologies: rhumatological, neurological, congenital (giving hyperextensive articulations as a result)
* Corticoids allergy
* Infection within the treated zone
* Trauma antecedents at the level of the tendons.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brugmann University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Socorro ORTIZ

Head of clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nader Chahidi, MD

Role: STUDY_DIRECTOR

Clinique du Parc Léopold

Locations

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CHU Brugmann

Brussels, , Belgium

Site Status

Clinique du Parc Leopold

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Freiberg A, Pollard BA, Macdonald MR, Duncan MJ. Management of proximal interphalangeal joint injuries. J Trauma. 1999 Mar;46(3):523-8. doi: 10.1097/00005373-199903000-00033. No abstract available.

Reference Type BACKGROUND
PMID: 10088864 (View on PubMed)

Chalmer J, Blakeway M, Adams Z, Milan SJ. Conservative interventions for treating hyperextension injuries of the proximal interphalangeal joints of the fingers. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD009030. doi: 10.1002/14651858.CD009030.pub2.

Reference Type BACKGROUND
PMID: 23450596 (View on PubMed)

Paschos NK, Abuhemoud K, Gantsos A, Mitsionis GI, Georgoulis AD. Management of proximal interphalangeal joint hyperextension injuries: a randomized controlled trial. J Hand Surg Am. 2014 Mar;39(3):449-54. doi: 10.1016/j.jhsa.2013.11.038. Epub 2014 Feb 4.

Reference Type BACKGROUND
PMID: 24503231 (View on PubMed)

Micev AJ, Saucedo JM, Kalainov DM, Wang L, Ma M, Yaffe MA. Surgical Techniques for Correction of Traumatic Hyperextension Instability of the Proximal Interphalangeal Joint: A Biomechanical Study. J Hand Surg Am. 2015 Aug;40(8):1631-7. doi: 10.1016/j.jhsa.2015.05.011. Epub 2015 Jul 3.

Reference Type BACKGROUND
PMID: 26143967 (View on PubMed)

Other Identifiers

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CHUB-Diprophos-IPP

Identifier Type: -

Identifier Source: org_study_id

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