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

Primary Purpose

Sprain

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Diprophos
Sponsored by
Brugmann University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sprain focused on measuring sprains of the proximal interphalangeal joints of the long fingers, Diprophos

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Brugmann
  • Clinique du Parc Leopold

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diprophos

Control group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Flexion/extension deficit
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
Flexion/extension deficit
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
Flexion/extension deficit
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
Laxity in hyperextension
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
Laxity in hyperextension
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
Laxity in hyperextension
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer
Diameter of the articulation
Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio
Diameter of the articulation
Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio
Diameter of the articulation
Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio
Prehension force
Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.
Prehension force
Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.
Prehension force
Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.

Secondary Outcome Measures

EVA scale
Pain assessment at the level of the volar plate
EVA scale
Pain assessment at the level of the volar plate
Mini-DASH
Assessment of the return to daily life activities or sport activities. Questionnaire of the Disabilities of the Arm, Shoulder and Hand.
Mini-DASH
Assessment of the return to daily life activities or sport activities. Questionnaire of the Disabilities of the Arm, Shoulder and Hand.
Mitchigan Hand Questionnaire
Auto-evaluation of the patient regarding the functionality of his/her articulation
Mitchigan Hand Questionnaire
Auto-evaluation of the patient regarding the functionality of his/her articulation

Full Information

First Posted
September 26, 2016
Last Updated
August 5, 2020
Sponsor
Brugmann University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02916940
Brief Title
Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers.
Official Title
Randomized Controlled Prospective Study on the Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers (Thumb Excluded).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 16, 2016 (Actual)
Primary Completion Date
February 11, 2020 (Actual)
Study Completion Date
February 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brugmann University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sprain
Keywords
sprains of the proximal interphalangeal joints of the long fingers, Diprophos

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diprophos
Arm Type
Experimental
Arm Description
Patients having had a sprain of the long fingers, within 2 weeks of consultation. This group will receive a single injection of corticoids.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Diprophos
Intervention Description
Single subcutaneous injection of Diprophos, in the acute phase.
Primary Outcome Measure Information:
Title
Flexion/extension deficit
Description
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
Time Frame
Baseline (day of kenacort injection)
Title
Flexion/extension deficit
Description
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
Time Frame
7 days after injection
Title
Flexion/extension deficit
Description
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
Time Frame
30 days after injection
Title
Laxity in hyperextension
Description
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
Time Frame
Baseline (day of kenacort injection)
Title
Laxity in hyperextension
Description
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer.
Time Frame
7 days after injection
Title
Laxity in hyperextension
Description
Evaluation of the maximal amplitude of the articulation, as measured by a goniometer
Time Frame
30 days after injection
Title
Diameter of the articulation
Description
Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio
Time Frame
Baseline (day of kenacort injection)
Title
Diameter of the articulation
Description
Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio
Time Frame
7 days after injection
Title
Diameter of the articulation
Description
Oedema evaluation. Collateral comparison with the same finger of the other hand: result expressed as a ratio
Time Frame
30 days after injection
Title
Prehension force
Description
Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.
Time Frame
Baseline (day of kenacort injection)
Title
Prehension force
Description
Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.
Time Frame
7 days after injection
Title
Prehension force
Description
Assessed by a dynamometer (Jamar hydraulic gauge). Result expressed as a ratio with the prehension force of the non-injured hand.
Time Frame
30 days after injection
Secondary Outcome Measure Information:
Title
EVA scale
Description
Pain assessment at the level of the volar plate
Time Frame
7 days after injection
Title
EVA scale
Description
Pain assessment at the level of the volar plate
Time Frame
30 days after injection
Title
Mini-DASH
Description
Assessment of the return to daily life activities or sport activities. Questionnaire of the Disabilities of the Arm, Shoulder and Hand.
Time Frame
7 days after injection
Title
Mini-DASH
Description
Assessment of the return to daily life activities or sport activities. Questionnaire of the Disabilities of the Arm, Shoulder and Hand.
Time Frame
30 days after injection
Title
Mitchigan Hand Questionnaire
Description
Auto-evaluation of the patient regarding the functionality of his/her articulation
Time Frame
7 days after injection
Title
Mitchigan Hand Questionnaire
Description
Auto-evaluation of the patient regarding the functionality of his/her articulation
Time Frame
30 days after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nader Chahidi, MD
Organizational Affiliation
Clinique du Parc Léopold
Official's Role
Study Director
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Clinique du Parc Leopold
City
Brussels
ZIP/Postal Code
1040
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10088864
Citation
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.
Results Reference
background
PubMed Identifier
23450596
Citation
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;(2):CD009030. doi: 10.1002/14651858.CD009030.pub2.
Results Reference
background
PubMed Identifier
24503231
Citation
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.
Results Reference
background
PubMed Identifier
26143967
Citation
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.
Results Reference
background

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

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