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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03623269
Other study ID # ORIF.005
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date December 31, 2024

Study information

Verified date May 2019
Source The Orthopaedic Research & Innovation Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 31
Est. completion date December 31, 2024
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. English speaking

2. >18 years of age

3. Underwent posterior approach to total shoulder arthroplasty by Dr. Michael Greiwe at St. Elizabeth Healthcare

Exclusion Criteria:

1. Non-English speaking

2. <18 years of age

3. Loose bone in the anterior recess of the shoulder

4. Severe arthritis with significant bony deformity

Study Design


Intervention

Procedure:
posterior approach to total shoulder arthroplasty
The posterior approach to total shoulder arthroplasty approaches the patient from the back of the shoulder and spares the rotator cuff.

Locations

Country Name City State
United States The Orthopaedic Research & Innovation Foundation Edgewood Kentucky

Sponsors (1)

Lead Sponsor Collaborator
The Orthopaedic Research & Innovation Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary recovery American shoulder and elbow score (ASES) with a range from 0-100, with 0 being worst outcome and 100 being best outcome preoperative to 6 months postoperatively
Primary recovery Simple Shoulder Test score (SST) with a range from 0-12 with 12 being the best score and 0 being the worst score. preoperative to 6 months postoperatively
Primary recovery range of motion preoperative to 6 months postoperatively
Primary complications percent of complications 6 months postoperative
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