Clinical trial NCT02916940: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sprain
Keywords: sprains of the proximal interphalangeal joints of the long fingers
Diprophos
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Flexion/extension deficit
timeFrame: Baseline (day of kenacort injection)
measure: Flexion/extension deficit
timeFrame: 7 days after injection
measure: Flexion/extension deficit
timeFrame: 30 days after injection
measure: Laxity in hyperextension
timeFrame: Baseline (day of kenacort injection)
measure: Laxity in hyperextension
timeFrame: 7 days after injection
measure: Laxity in hyperextension
timeFrame: 30 days after injection
measure: Diameter of the articulation
timeFrame: Baseline (day of kenacort injection)
measure: Diameter of the articulation
timeFrame: 7 days after injection
measure: Diameter of the articulation
timeFrame: 30 days after injection
measure: Prehension force
timeFrame: Baseline (day of kenacort injection)
measure: Prehension force
timeFrame: 7 days after injection
measure: Prehension force
timeFrame: 30 days after injection
Secondary outcomes:
measure: EVA scale
timeFrame: 7 days after injection
measure: EVA scale
timeFrame: 30 days after injection
measure: Mini-DASH
timeFrame: 7 days after injection
measure: Mini-DASH
timeFrame: 30 days after injection
measure: Mitchigan Hand Questionnaire
timeFrame: 7 days after injection
measure: Mitchigan Hand Questionnaire
timeFrame: 30 days after injection
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
city: Brussels
country: Belgium
facility: Clinique du Parc Leopold
Study officials:
affiliation: Clinique du Parc Léopold
name: Nader Chahidi, MD
role: STUDY_DIRECTOR
References:
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.
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;2013(2):CD009030. doi: 10.1002/14651858.CD009030.pub2.
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.
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.