A Novel Splint Technique for Distal Radius Treatment

NCT04432740 | Completed

• 1 other identifier: B.10.1.TKH.4.34.H.GP.0.01/45
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Distal Radius Fracture; Complication of Treatment

Keywords

distal radius fracture; conservative treatment; reverse sugar tong; below arm cast

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Health relaated quality of life

  6th week

• Rate of Complications Outcomes

  1st week, 3rd week and 6th week

• Functional Outcomes

  12th week and 1st year

• Functional Outcomes

  12th week and 1st year

Study Arms (2)

Below Arm Cast Group

ACTIVE COMPARATOR

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

Reverse Sugar Tong Group

ACTIVE COMPARATOR

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

Interventions

Conservative Treatment of Distal Radius Fracture PROCEDURE

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.

Below Arm Cast Group; Reverse Sugar Tong Group

Eligibility Criteria

• Age: 18 Years - 61 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Training and Research Hospital

Istanbul, Umraniye, 34760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 16, 2020
• Study Start: April 15, 2017
• Primary Completion: April 20, 2018
• Study Completion: May 1, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)