A Novel Splint Technique for Distal Radius Treatment

Distal Radius Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432740
• Other study ID #: B.10.1.TKH.4.34.H.GP.0.01/45
• Status: Completed
• Phase: N/A
• Start date: April 15, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: June 2020
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 1, 2019
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication of Treatment
• Distal Radius Fracture
• Fractures, Bone
• Radius Fractures

Intervention

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.

Locations

Country	Name	City	State
Turkey	Umraniye Training and Research Hospital	Istanbul	Umraniye

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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