NCT02916940

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2016

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 16, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

3.2 years

First QC Date

September 26, 2016

Last Update Submit

August 5, 2020

Conditions

Sprain

Keywords

sprains of the proximal interphalangeal joints of the long fingersDiprophos

Outcome Measures

Primary Outcomes (12)

  • Flexion/extension deficit

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

    Baseline (day of kenacort injection)

  • Flexion/extension deficit

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

    7 days after injection

  • Flexion/extension deficit

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

    30 days after injection

  • Laxity in hyperextension

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

    Baseline (day of kenacort injection)

  • Laxity in hyperextension

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.

    7 days after injection

  • Laxity in hyperextension

    Evaluation of the maximal amplitude of the articulation, as measured by a goniometer

    30 days after injection

  • Diameter of the articulation

    Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio

    Baseline (day of kenacort injection)

  • Diameter of the articulation

    Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio

    7 days after injection

  • Diameter of the articulation

    Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio

    30 days after injection

  • Prehension force

    Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.

    Baseline (day of kenacort injection)

  • Prehension force

    Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.

    7 days after injection

  • Prehension force

    Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.

    30 days after injection

Secondary Outcomes (6)

  • EVA scale

    7 days after injection

  • EVA scale

    30 days after injection

  • Mini-DASH

    7 days after injection

  • Mini-DASH

    30 days after injection

  • Mitchigan Hand Questionnaire

    7 days after injection

  • +1 more secondary outcomes

Study Arms (2)

Diprophos

EXPERIMENTAL

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

Drug: Diprophos

Control group

NO INTERVENTION

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.

Interventions

DiprophosDRUG

Single subcutaneous injection of Diprophos, in the acute phase.

Diprophos

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Brugmann

Brussels, 1020, Belgium

Location

Clinique du Parc Leopold

Brussels, 1040, Belgium

Location

Related Publications (4)

  • 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.

    PMID: 10088864BACKGROUND

  • 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.

    PMID: 23450596BACKGROUND

  • 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.

    PMID: 24503231BACKGROUND

  • 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.

    PMID: 26143967BACKGROUND

MeSH Terms

Conditions

Sprains and Strains

Interventions

betamethasone dipropionate, betamethasone sodium phosphate drug combination

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Nader Chahidi, MD

    Clinique du Parc LĂ©opold

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 28, 2016

Study Start

November 16, 2016

Primary Completion

February 11, 2020

Study Completion

February 11, 2020

Last Updated

August 6, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)