Clinical trial NCT03126175: Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures
Official title: Above-versus Below-elbow Casting for Conservative Treatment of Distal Radius Fractures: a Randomized Controlled Trial and Study Protocol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: conservative treatment, treatment outcome
Lead sponsor: Hospital Dr. Fernando Mauro Pires da Rocha
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
First posted: 2017-04-24
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: For the non-surgical treatment of distal radius fractures in adults a variety cast options are available, including or not the elbow joint. The literature is inconclusive regarding the need to immobilize the elbow joint after reduction of the distal radius fracture.This study was undertaken to evaluate the best method of immobilization between the above and below-elbow cast groups at the end of 6 months of follow-up.

Detailed description: To determine the best method of immobilization ( below elbow versus above elbow splint) in patients with distal radius fractures at the end of 6 months of follow-up:

* Type of study: Prospective, randomized and controlled trial.
* Patient recruitment: Adults attended in emergency room with closed acute displaced distal radius fracture will be reduced under general venous anesthesia with fluoroscopic control.

Displaced and reducible fractures (after venous anesthesia) will be included if one of these conditions is present: Radial height - loss \> 2 mm , radial Inclination- loss \> 4°, dorsal tilt - \> 10°, ulnar variance - loss \> 3 mm, intra-articular step off or gap - \> 2mm . The contralateral side will be used as a reference.

The eligible participants will be informed about the nature and purpose of the study by reading the "Informed Consent Term" after ageeement, patients will included in the trial and randomized.

* Maintenace of reduction will be defined as the maintenance of the parameters listed above.
* Patients with above elbow immobilization will remain for 4 weeks with splint followed by 2 weeks of below elbow immobilization. The immobilization will be removed with 6 weeks.
* The primary outcome is: maintenance of reduction by evaluation of radiographic parameters (wrist radiographs) at one, two, three, four, six, eight, twelve and twenty four weeks after fracture reduction and self-reported function assessment Disabilities of the Arm, Shoulder and Hand questionnaire(DASH).
* Secondary outcomes:Patient Rated Wrist Evaluation- PRWE. Pain (VAS - "Visual Analogue Pain Scale"). Objective functional evaluation (goniometry and dynamometry) and rate of complications and failures.
* Sample Size calculation was calculated based on data derived from one recent randomized clinical trial on the subject. We considered as relevant differences on DASH scores (clinically relevant) when scores are greater than 10 points and standard deviation 15 points. To detect this difference (Student T-test) and statistical power of 95% resulted in a 58 patient sample size per group. We considered an extra 10% for balancing follow up losses. Thus, our inclusion target will be 64 patients per group. We considered the test as bicaudal.

Benefits: Below elbow splinting is easier to apply, lower cost, more comfortable and permits better function for daily life activity.

Eligibility criteria: Inclusion Criteria:

* Adults with growth plate closured, both gender, with closed acute displaced distal radius fracture (up to 1 week), associated or not with the ulnar styloid fractures with no other fractures, which may be closed reduced after intravenous anesthesia. No previous fractures to the ipsilateral or contralateral forearm.
* Displaced and reducible fractures (after venous anesthesia) classified by AO as type A2, A3, C1, C2 and C3.

Exclusion Criteria:

* Open fractures.
* Vascular ou neurological compromise

Primary outcomes:
measure: maintenance of reduction by evaluation of radiographic parameters (wrist radiographs).
timeFrame: One, two, three, four, six, eight, twelve and twenty four weeks after fracture reduction(radiographs).
Secondary outcomes:
measure: DASH questionnaire
timeFrame: Two, six , eight, twelve and twenty four weeks
measure: Patient Rated Wrist Evaluation (PRWE)
timeFrame: Eight, twelve and twenty four weeks.
measure: Pain (VAS - "Visual Analogue Pain Scale").
timeFrame: one, two, three, four, six, eight, twelve and twenty four weeks after fracture reduction
measure: Objective functional evaluation (goniometry and dynamometry)
timeFrame: Six, eight, twelve and twenty four weeks follow up visit.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Municipal Dr. Fernando Mauro Pires da Rocha
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: João Carlos Belloti, PhD
role: STUDY_DIRECTOR
References:
citation: Bunger C, Solund K, Rasmussen P. Early results after Colles' fracture: functional bracing in supination vs dorsal plaster immobilization. Arch Orthop Trauma Surg (1978). 1984;103(4):251-6. doi: 10.1007/BF00387330.
citation: Bong MR, Egol KA, Leibman M, Koval KJ. A comparison of immediate postreduction splinting constructs for controlling initial displacement of fractures of the distal radius: a prospective randomized study of long-arm versus short-arm splinting. J Hand Surg Am. 2006 May-Jun;31(5):766-70. doi: 10.1016/j.jhsa.2006.01.016.
citation: Stewart HD, Innes AR, Burke FD. Functional cast-bracing for Colles' fractures. A comparison between cast-bracing and conventional plaster casts. J Bone Joint Surg Br. 1984 Nov;66(5):749-53. doi: 10.1302/0301-620X.66B5.6389558.
citation: Bohm ER, Bubbar V, Yong Hing K, Dzus A. Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial. J Bone Joint Surg Am. 2006 Jan;88(1):1-8. doi: 10.2106/JBJS.E.00320.
citation: Pool C. Colles's fracture. A prospective study of treatment. J Bone Joint Surg Br. 1973 Aug;55(3):540-4. No abstract available.
citation: Sarmiento A, Pratt GW, Berry NC, Sinclair WF. Colles' fractures. Functional bracing in supination. J Bone Joint Surg Am. 1975 Apr;57(3):311-7.
citation: Okamura A, de Mendonca GM, Raduan Neto J, de Moraes VY, Faloppa F, Belloti JC. Above-versus below-elbow casting for conservative treatment of distal radius fractures: a randomized controlled trial and study protocol. BMC Musculoskelet Disord. 2018 Mar 27;19(1):92. doi: 10.1186/s12891-018-2007-9.