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A Novel Splint Technique for Distal Radius Treatment

Primary Purpose

Distal Radius Fracture, Complication of Treatment

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conservative Treatment of Distal Radius Fracture
Sponsored by
Umraniye Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring distal radius fracture, conservative treatment, reverse sugar tong, below arm cast

Eligibility Criteria

18 Years - 61 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Umraniye Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Below Arm Cast Group

Reverse Sugar Tong Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.

Full Information

First Posted
May 29, 2020
Last Updated
June 11, 2020
Sponsor
Umraniye Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04432740
Brief Title
A Novel Splint Technique for Distal Radius Treatment
Official Title
Clinical Outcomes Comparison of Distal Radius Fractures Between Two Conservative Treatment Methods: Below-Arm Cast Versus Reverse Sugar Tong Splint
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umraniye Education and Research 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Complication of Treatment
Keywords
distal radius fracture, conservative treatment, reverse sugar tong, below arm cast

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Below Arm Cast Group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Reverse Sugar Tong Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Conservative Treatment of Distal Radius Fracture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fracture Healing Outcome
Description
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.
Time Frame
6th week
Secondary Outcome Measure Information:
Title
Health relaated quality of life
Description
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.
Time Frame
6th week
Title
Rate of Complications Outcomes
Description
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.
Time Frame
1st week, 3rd week and 6th week
Title
Functional Outcomes
Description
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).
Time Frame
12th week and 1st year
Title
Functional Outcomes
Description
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.
Time Frame
12th week and 1st year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Umraniye Training and Research Hospital
City
Istanbul
State/Province
Umraniye
ZIP/Postal Code
34760
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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A Novel Splint Technique for Distal Radius Treatment

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