DenCT Shoulder Bone Quality Evaluation

NCT06032416 | Not Yet Recruiting

• 1 other identifier: CSG2023-05E
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis Shoulder; Rotator Cuff Tears

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Functional Performance (Optional): Constant & Murley Score

  Pre-op

Study Arms (1)

Shoulder Arthroplasty

OTHER

Patients in need of a shoulder arthroplasty

Radiation: Preoperative CT Scan

Interventions

Preoperative CT Scan RADIATION

Preoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses.

Shoulder Arthroplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead
• Zimmer, GmbH: collaborator

Study Sites (1)

Joint Surgery, Sports Clinic Ishinomaki

Ishinomaki, Miyagi, Japan

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• Elliott Goff, PhD

  Zimmer, GmbH

  STUDY CHAIR

Central Study Contacts

Elliott Goff, PhD

CONTACT

41792222308; elliott.goff@zimmerbiomet.com

Ghislain Maquer

CONTACT

ghislain.maquer@zimmerbiomet.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 13, 2023
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)