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NCT Number: NCT05615259

Comparison Between Exactech Guided Personalized Surgery (GPS) and Conventional Instrumentation of Shoulder Arthroplasty

The primary objective of this study is to examine the optimization of Reverse Shouder Arthroplasty implant position between GPS and conventional techniques. The secondary objective is to assess the effect of implant position using GPS vs. conventional techniques on ROM and patient reported outcomes. Long-term follow-up to 10 years with minimum 2 year follow-up for patients.

Recruiting

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Key information

Conditions

Technology Comparison

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dijklander Ziekenhuis

Hoorn, 1624 NP, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is at least 21 years of age at the time of surgery
  • Patient is indicated for reverse shoulder arthroplasty
  • Patient is willing to participate by complying with pre- and postoperative visit requirements
  • Patient is willing to participate for the entire length of the prescribed follow-up (minimum 2 years)
  • Patient is willing and able to review and sign a study informed consent form
  • Preop CT scan is within 3 months of the date of surgery

Exclusion criteria

  • Revision shoulder arthroplasty
  • Reverse shoulder arthroplasty for fracture
  • Need for structural glenoid bone graft
  • Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved
  • Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis
  • Neuromuscular disorders that do not allow control of the joint
  • Significant injury to the brachial plexus
  • Non-functional deltoid muscles
  • The patient is unwilling or unable to comply with the post-operative care instructions
  • Patients who are a known drug or alcohol abuser, or have a psychological disorder (e.g. schizophrenia major depression, bipolar disorder, etc.) as defined by the DSM4 that affect follow-up care or treatment outcomes.
  • Alcohol, drug, or other subtance abuse
  • Any disease state that could adversaly affect the function or longevity of the implant
  • Patient is pregnant
  • Patient is a prisoner
  • Patient who are currently involved in any personal injury litigation, medical-legal or worker's compensation claims

Treatment and study plan

Primary outcomes

  1. SST-12

    Time frame: Through study completion, an average of 1 per year

    Shoulder Simple Test (SST) - 12 questions with yes/no responses that measure shoulder pain and function from a patient's perspective - 12 yes corresponds to 100%

  2. SPADI

    Time frame: Through study completion, an average of 1 per year

    Shoulder Pain and Disability Index (SPADI) -13 questions assessing about pain scale (5 questions) and disability scale (8 questions) where 0 indicates no pain/no difficulty and 10 indicates worst pain imaginable/so difficult it requires help while performin these activities

  3. Constant

    Time frame: Through study completion, an average of 1 per year

    Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain

  4. ASES

    Time frame: Through study completion, an average of 1 per year

    American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition

  5. UCLA

    Time frame: Through study completion, an average of 1 per year

    University of California Los Angeles Shoulder Score (UCLA) - 5 Items score which combines both physician (3 items) and patient assessment (2 items) whith a total range from 0-35 where 0 indicates worse shoulder function and 35 better shoulder function outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Rachael Craig

CONTACT

[email protected]

352-377-1140

Sandrine Angibaud

CONTACT

[email protected]

352-377-1140

Sponsors and collaborators

Lead sponsor

Exactech

Industry

Registry information

Official study title

A Prospective, Multi-Center, Randomized Clinical Study of Total Shoulder Arthroplasty Comparing Exactech Guided Personalized Surgery (GPS) vs. Conventional Instrumentation

Important dates

Study start
2020
Primary completion
2030
Study completion
2031
First posted
Nov 14, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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