pTSA: Posterior Approach to Total Shoulder Arthroplasty

• Sponsor: The Orthopaedic Research & Innovation Foundation (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03623269
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Anticipated Duration (Months): 87
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Total Shoulder Arthroplasty; Osteo Arthritis Shoulders	Procedure: posterior approach to total shoulder arthroplasty

Study Design

• Study Type: Observational
• Actual Enrollment: 31 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Posterior Approach to Total Shoulder Arthroplasty: A Data Analysis on Patients Undergoing the Posterior Approach to Total Shoulder Arthroplasty
• Actual Study Start Date: Oct 1, 2017
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Outcome Measures

Primary Outcome Measures

1. recovery [preoperative to 6 months postoperatively]

   American shoulder and elbow score (ASES) with a range from 0-100, with 0 being worst outcome and 100 being best outcome

2. recovery [preoperative to 6 months postoperatively]

   Simple Shoulder Test score (SST) with a range from 0-12 with 12 being the best score and 0 being the worst score.

3. recovery [preoperative to 6 months postoperatively]

   range of motion

4. complications [6 months postoperative]

   percent of complications

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Orthopaedic Research & Innovation Foundation	Edgewood	Kentucky	United States	41017

Sponsors and Collaborators

• The Orthopaedic Research & Innovation Foundation

Investigators

• Principal Investigator: R M Greiwe, MD, The Orthopaedic Research & Innovation Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Orthopaedic Research & Innovation Foundation
• ClinicalTrials.gov Identifier: NCT03623269
• Other Study ID Numbers: ORIF.005
• First Posted: Aug 9, 2018
• Last Update Posted: May 30, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis

Study Results

No Results Posted as of May 30, 2019