Customized Polyamide Prosthesis. for Mid Shaft Clavicle Fracture

NCT05261308 | Completed DMC

• 1 other identifier: polyamide
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

Herein we describe the management of a patient who presented with progressive brachial plexopathy following the initial nonoperative management of a mid shaft clavicular fracture by using 3 D customized polyamide prosthesis.

Conditions

Treatment Adherence and Compliance

Outcome Measures

Primary Outcomes (1)

• American shoulder and elbow surgeons score Special Score for shoulder pain and function

  American shoulder and elbow surgeons score Special Score for shoulder pain and function. The American shoulder and elbow surgeons score is a composite instrument, requiring both a physician assessment and a patient-completed portion. . This includes a section on pain (7 items) and a section on activities of daily living (10 items). Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. Intensity of pain: 0; Putting on a coat is not difficult; Sleeping on the affected side is not difficult; Washing my back/doing up my bra is not difficult; Managing toiletting is not difficult; Combing my hair is not difficult; Reaching a high shelf is not difficult; Lifting 10lbs. (4.5kg) above my shoulder is not difficult; Throwing a ball overhand is not difficult; Doing my usual work is not difficult; Doing my usual sport/leisure activity is not difficult; It means good shoulder

  after 2 and half years

Study Arms (1)

prosthesis

EXPERIMENTAL

The polyamide prosthesis

Other: new prosthesis

Interventions

new prosthesis OTHER

Operation to fix the new prosthesis

prosthesis

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• fracture midshaft clavicle

You may not qualify if:

• normal clavicle

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Sahar Abdalbary

Cairo, Select State/province, 11431, Egypt

Location

Sahar

Cairo, 11431, Egypt

Location

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Sahar Abdalbary, professor

  Nahda University, Faculty of Physical Therapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 2, 2022
• Study Start: March 16, 2018
• Primary Completion: August 14, 2019
• Study Completion: April 18, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: by2and half years
• Access Criteria: the criteria will be discussed later

Locations

EG (2)