DenCT Shoulder Bone Quality Evaluation

Collection of CT Images to Evaluate Bone Quality Before Total Shoulder Arthroplasty

The objective of the study is to evaluate the preoperative bone quality assessment based on CT to later establish a scale for the decision of stemless shoulder arthroplasty.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tears; Osteoarthritis Shoulder
• Intervention / Treatment: Radiation: Preoperative CT Scan

Detailed Description

The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality. Therefore, this study is not centered around a specific device and any primary shoulder arthroplasty system from Zimmer Biomet including anatomical, hemi, or reverse, stemmed or stemless configurations can be used for the target population. The indications of this study are the shoulder joint diseases such as osteoarthritis and the irreparable rotator cuff tears which are needed with TSA/RSA. The subjects should be also met the inclusion/exclusion criteria. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elliott Goff, PhD; Phone Number: 41792222308; Email: elliott.goff@zimmerbiomet.com
• Study Contact Backup: Name: Ghislain Maquer; Email: ghislain.maquer@zimmerbiomet.com

Study Locations

• Japan
  • Miyagi
    • Ishinomaki, Miyagi, Japan
      • Joint Surgery, Sports Clinic Ishinomaki
      • Contact: Taku Hatta, PhD; Phone Number: +81-225-98-9901; Email: t-hatta@jss-clinic.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient must be older than 18 years and skeletally mature.
• Patient must undergo the SHA, TSA, or RSA according to the Instructions for Use (IFU).
• Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
• Patient is a candidate for lateral or bi-lateral shoulder arthroplasty due to one or more of the following:
• Non-inflammatory degenerative joint disease including osteoarthritis.
• Avascular necrosis of the humeral head.
• Autoimmune disease including rheumatoid arthritis.
• Irreparable rotator cuff tears.
• Correction of functional deformity.
• Patient must be able and willing to sign the IRB/EC approved informed consent.
• Patient must be able to undergo a preoperative CT scan
• Patient must be willing to share their CT images with sponsor

Exclusion Criteria:

• Patient is a candidate for shoulder arthroplasty due to one or more of the following:
• Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
• Revision TSA/RSA after the prior TSA/RSA.
• Patient has experienced the traumatic fractures to the implant site.
• Patient is unwilling or unable to give consent
• Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study, e.g., any neuromuscular disease compromising the affected limb.
• Patient is known to be pregnant or breastfeeding.
• Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non- compliant).
• Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
• Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.
• Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Shoulder Arthroplasty; Patients in need of a shoulder arthroplasty	Radiation: Preoperative CT Scan; Preoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CT scan data acquisition	The primary endpoint is the collection of the preoperative CT scan with a calibration phantom at each site and the surgeon's intraoperative evaluation of bone quality.	Immediate post-op
Intra-op bone quality evaluation: Thumb Test	The first test is the Thumb test that occurs just after the head resection. The surgeon presses his/her thumb on the resected humeral surface to assess bone quality. If he can depress the thumb into the humerus without much resistance, then primary stability of the stemless implant may be insufficient.	Intra-op
Intra-op bone quality evaluation: Pin Test	The second test is the Pin test where the central pin used to position the trial head is wiggled to assess bone quality. If the central pin is unstable in the humerus, then this may indicate that the bone is soft/weak.	Intra-op
Intra-op bone quality evaluation: Broach Test	The third test is the Broach (or Puncher test) where the impactor is wiggled to assess bone quality. If the puncher is unstable after impaction, then the bone is soft/weak, and a stemmed prosthesis is recommended.	Intra-op
Duplicate CT scan data acquisition (Optional)	Additional primary endpoint for a sub-cohort of a maximum of 30 patients. These patients will receive a second preoperative CT scan after a changing position (patient repositioning), which is needed to evaluate the precision of the phantom-less method. This duplicated scan is considered optional in the study.	Immediate post-op

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Performance (Optional): Constant & Murley Score	The Constant & Murley Score (CMS) is a multi-item functional scale assessing pain, ADL, ROM and strength of the affected shoulder. Its score ranges from 0 to 100 points, representing worst and best shoulder function, respectively.	Pre-op

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Collaborators: Zimmer, GmbH
• Investigators: Study Chair: Elliott Goff, PhD, Zimmer, GmbH

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: September 4, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: CSG2023-05E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No