A Novel Splint Technique for Distal Radius Treatment

Clinical Outcomes Comparison of Distal Radius Fractures Between Two Conservative Treatment Methods: Below-Arm Cast Versus Reverse Sugar Tong Splint

There are many conservative treatment methods, including below arm cast, above arm cast, and sugar tong splint that aim to obtain maximum functional, clinical, and radiological results There are no clear indications with regard to the best treatment including conservative or surgical methods for the different fracture subtypes in distal radius fracture. The purpose of this prospective randomized study was to compare a new reverse sugar tong splint technique that does not immobilize the elbow with a below-arm cast, in terms of patient radiological and clinical outcomes and the ability to maintain fracture reduction.

Study Overview

• Status: Completed
• Conditions: Distal Radius Fracture; Complication of Treatment
• Intervention / Treatment: Procedure: Conservative Treatment of Distal Radius Fracture

Detailed Description

This study was conducted at a single Orthopedics and Traumatology emergency department center between April 2017 and March 2019. A two-arm, parallel-group, prospective randomized trial was conducted to compare below-arm cast (BAC) and reverse sugar tong (RST) (described below) treatment of DRF.

Overall, 231 patients diagnosed with distal radius fracture in the emergency department received prospective treatment.

Inclusion criteria: Patients aged >18 years and with distal radius fracture type A and B (who presented within 10 days of the injury) were considered for inclusion.

Exclusion criteria: Patients with AO type C distal radius fractures (treated surgically), type 2 and 3 open fractures (according to Gustilo classification), previous hand or wrist surgery, fractures in the concomitant side of the upper extremities, associate carpal fracture, deformity on same extremity, pathological fractures, and cognitive deficit that does not allow the patient to understand the functional evaluation were excluded from this study. Lastly, patients who did not return for a follow-up visit at the end of the cast or splint treatment were also excluded.

Patient selection and treatment methods Sample Size: The sample size was calculated based on a 15-20% difference in complication rate between the two treatment groups, an alpha level of 5% and a power of 80%. Consequently, each group shall at least consist of 55 participants. We considered an extra 20% who loss of follow-up or loss of reduction and surgery may require for balancing sample size. With expectation of dropouts70 patients per group were included.

All the initial fractures of the patients were classified by the same author using the AO classification. Patients were randomly allocated to a treatment group using an electronic random number generator, with those having an even number assigned to the BAC group and those having an odd number to the RST group. Treatment in both the BAC and RST groups was conducted by the same investigator. The reduction obtained was checked on AP and lateral x-ray of the wrist, which were then used to calculate the following baseline radiological parameters: radial inclination (RI), radial height (RH), and volar tilt (VT).

Follow-up Management Clinical and radiological follow-up was performed 7-10 days (initial follow-up), three weeks, 5 or 6 weeks, 12 weeks and one year (last follow-up) after the treatment. X-rays at the initial follow-up which was performed 7-10 days after the initial closed reduction were taken with the cast or splint in place. Maintenance of fracture reduction was defined as a loss of reduction of less than 2 mm of radial height, 5° of radial inclination or 10° of volar tilt from the initial reduction films, and/or less than 2 mm of intra-articular step-off. In the initial follow-up, third week, and 6th week visit, patients were evaluated with x-ray to detect cast and splint complications, including those that require cast wedging or valving to reduce the pressure and the presence of complex regional pain syndrome (CRPS). Both treatments were removed during the 5-6th week visit in all groups.

Functional outcomes The validated quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire score and the Mayo Elbow Performance score (MEPS) score were used to measure clinical outcomes.These scores were performed at the12th week and last follow-up visit for all the patients. Both groups were also evaluated with the Health Assessment Questionnaire (HAQ) at the 6th week visit for health status.

Radiological evaluation All the radiological parameters were measured by the same author at two time points: initial visit postreduction and 6th visit after the end of treatment. Radial height, Radial inclination and Volar tilt were measured separetly.

Clinical evaluations The wrist range of motion was measured in degree, using a goniometer, from the neutral position to flexion, extension, radial deviation, and ulnar deviation by same investigator during the last follow-up visit. The forearm rotation was also measured.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Umraniye
    • Istanbul, Umraniye, Turkey, 34760
      • Umraniye Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 61 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged >18 years,
• with distal radius fracture type A and B (who presented within 10 days of the injury)

Exclusion Criteria:

• Patients with AO type C distal radius fractures (treated surgically),
• type 2 and 3 open fractures (according to Gustilo classification),
• previous hand or wrist surgery,
• fractures in the concomitant side of the upper extremities,
• associate carpal fracture, deformity on the same extremity,
• pathological fractures,
• cognitive deficit that does not allow the patient to understand the functional evaluation
• patients who did not return for a follow-up visit at the end of the cast or splint treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Below Arm Cast Group; All the patients were prepared in the supine position at the emergency department. For analgesia, we used the hematoma block technique with 3 cc of 2% prilocaine hydrochloride®. In this group, after traction was applied using a finger-trap traction with a 4.5 kg weight for 5 minutes, the standard below arm cast was applied. Patients were encouraged to actively move their fingers, ipsilateral shoulder, and elbow in all the groups. Both treatments lasted 5 or 6 weeks after at our clinic	Procedure: Conservative Treatment of Distal Radius Fracture; The purpose of this prospective randomized study was to compare a new reverse sugar tong splint technique that does not immobilize the elbow with a below-arm cast, in terms of patient radiological and clinical outcomes and the ability to maintain fracture reduction.
Active Comparator: Reverse Sugar Tong Group; In this group, after traction was applied using a finger-trap traction with a 4.5 kg weight for 5 minutes, sugar tong splint made of 12 layers of plaster was performed by one person. The reverse sugar tong splint succeeds as a classic sugar tong splint by stabilizing the volar and dorsal aspects of the wrist and forearm, maintaining the same degree of immobilization. The splint fold is located distally at the first web space of the hand, which does not immobilize the elbow. In all the groups, the wrist immobilization position was the same; pronated forearm, 15-20° wrist flexion, ulnar deviation, and care was taken not to immobilize the metacarpophalangeal joints. Patients were encouraged to actively move their fingers, ipsilateral shoulder, and elbow in all the groups. Both treatments lasted 5 or 6 weeks after at our clinic	Procedure: Conservative Treatment of Distal Radius Fracture; The purpose of this prospective randomized study was to compare a new reverse sugar tong splint technique that does not immobilize the elbow with a below-arm cast, in terms of patient radiological and clinical outcomes and the ability to maintain fracture reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fracture Healing Outcome	All patients were evaluated fracture healing with x-ray view which assessment of radiological union by observing the presence of bridging callus or the obscuration of the fracture line.	6th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health relaated quality of life	Both groups were also evaluated with the Health Assessment Questionnaire (HAQ) for quality of life. The HAQ score is a feasible scale consisting of 8 different categories totally with 20 items which beneficial for assessing the functional disabilities during activities of daily living which is the increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.	6th week
Rate of Complications Outcomes	All patients were evaluated with x-ray to detect cast and splint complications, including those that loss of reduction, require cast wedging or valving to reduce the pressure and the presence of complex regional pain syndrome.	1st week, 3rd week and 6th week
Functional Outcomes	Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH) questionnaire score was used to measure clinical outcomes.To calculate a QuickDASH score, at least 10 of the 11 items must be completed. Similar to the DASH, each item has 5 response options and, from the item scores, scale scores are calculated, ranging from 0 (no disability) to 100 (most severe disability).	12th week and 1st year
Functional Outcomes	Mayo Elbow Performance score (MEPS) score was used to measure clinical outcomes.The MEPS measures elbow function across four domains: pain (45 points), stability (10 points), range of motion (20 points), and daily functional tasks (25 points). Scores are categorized as 90-100 = excellent, 75-89 = good, 60-74 = fair, 0-59 = poor.	12th week and 1st year

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: conservative treatment; distal radius fracture; reverse sugar tong; below arm cast
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures
• Other Study ID Numbers: B.10.1.TKH.4.34.H.GP.0.01/45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No