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NCT01340391 Clinical Trial

Safety Study on a Wood-plastic Composite Cast

Distal Radius Fracture Clinical Trial

Official title:
A Wood-plastic Composite Cast - a New Ecological Splinting Method

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01340391
Other study ID # HUCS
Secondary ID
Status Enrolling by invitation
Phase N/A
First received March 28, 2011
Last updated April 21, 2011
Start date August 2009
Est. completion date June 2011

Study information
Verified date March 2011
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority Finland:National Supervisory Authority for Welfare and Health
Study type Interventional

Clinical Trial Summary

An ecologically friendly and biodegradable wood-plastic composite-cast is studied. Patients, who has sustained a distal radius fracture in need of splinting are requested to participate in the study.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 33
Est. completion date June 2011
Est. primary completion date April 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- distal radius fracture not older than 14 days

- age 17-90 years

- mother tongue finnish or swedish

Exclusion Criteria:

- open fracture

- other fractures or a previous fracture

- a previous or simultaneous tendon-, nerve- or vascular injury to the upper extremity

- a multiple injured hand

- decreased co-operation of the patient

- malignancy

- an illness affecting the general health

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Omnicast
dorsal splint 2-5 weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary How well will the material fulfil the demands of a splinting material The aim of the study was to evaluate how well the material fulfils the demands of a splinting material, the subjective satisfaction of the treatment and the orthopaedic technicians´opinion of the material.The following parameters will be detected: immobilisation-time, conservative / operative treatment, re-reposition, mechanical properties of the cast, skin appearance or irritation caused by the cast, allergic reactions and subjective opinion. 1 year Yes
See also
  Status Clinical Trial Phase
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Completed NCT04554472 - Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
Completed NCT03613922 - Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures N/A
Completed NCT01823692 - Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction Phase 2
Completed NCT02286661 - Short-Arm Casting Effective in Type A2 Fractures in the Distal Radius N/A
Completed NCT01062997 - Volar Locked Plating Versus Bridging External Fixation N/A
Not yet recruiting NCT04100317 - Spanning Bridged Plate in Comminuted Distal Radius Fractures
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Completed NCT03635060 - Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating N/A
Not yet recruiting NCT05095415 - Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting N/A
Terminated NCT02744352 - Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair N/A
Completed NCT05558306 - Radiological vs Clinical Outcome in DRF N/A
Completed NCT01778673 - Cortical Comminution and Intra-articular Involvement in Distal Radius Fractures Can Predict Radiological Outcome. A Prospective Multicenter Study N/A
Active, not recruiting NCT03349216 - Bier's Block Versus Systemic Analgesia Phase 2
Completed NCT04357470 - Manual Dexterity in Ulnar Styloid Fracture Patients N/A
Recruiting NCT02957240 - Graded Motor Imagery for Women at Risk for Developing Type I CRPS Following Closed Treatment of Distal Radius Fractures N/A
Completed NCT03240471 - Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization N/A
Terminated NCT04089709 - Well-arm Exercise in Distal Radius Fractures N/A
Completed NCT05623865 - The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures. N/A
Enrolling by invitation NCT04632745 - A Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly N/A