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DenCT Shoulder Bone Quality Evaluation

Primary Purpose

Osteoarthritis Shoulder, Rotator Cuff Tears

Status
Not yet recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Preoperative CT Scan
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoarthritis Shoulder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Joint Surgery, Sports Clinic Ishinomaki

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Shoulder Arthroplasty

Arm Description

Patients in need of a shoulder arthroplasty

Outcomes

Primary Outcome Measures

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.
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 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 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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2023
Last Updated
September 4, 2023
Sponsor
Zimmer Biomet
Collaborators
Zimmer, GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT06032416
Brief Title
DenCT Shoulder Bone Quality Evaluation
Official Title
Collection of CT Images to Evaluate Bone Quality Before Total Shoulder Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
Collaborators
Zimmer, GmbH

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Shoulder, Rotator Cuff Tears

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shoulder Arthroplasty
Arm Type
Other
Arm Description
Patients in need of a shoulder arthroplasty
Intervention Type
Radiation
Intervention Name(s)
Preoperative CT Scan
Intervention Description
Preoperative CT Scan including a bone density calibration phantom. This data will be compared with surgeon intra-operative CRF responses.
Primary Outcome Measure Information:
Title
CT scan data acquisition
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.
Time Frame
Immediate post-op
Title
Intra-op bone quality evaluation: Thumb Test
Description
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.
Time Frame
Intra-op
Title
Intra-op bone quality evaluation: Pin Test
Description
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.
Time Frame
Intra-op
Title
Intra-op bone quality evaluation: Broach Test
Description
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.
Time Frame
Intra-op
Title
Duplicate CT scan data acquisition (Optional)
Description
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.
Time Frame
Immediate post-op
Other Pre-specified Outcome Measures:
Title
Functional Performance (Optional): Constant & Murley Score
Description
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.
Time Frame
Pre-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elliott Goff, PhD
Phone
41792222308
Email
elliott.goff@zimmerbiomet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ghislain Maquer
Email
ghislain.maquer@zimmerbiomet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliott Goff, PhD
Organizational Affiliation
Zimmer, GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Joint Surgery, Sports Clinic Ishinomaki
City
Ishinomaki
State/Province
Miyagi
Country
Japan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taku Hatta, PhD
Phone
+81-225-98-9901
Email
t-hatta@jss-clinic.com

12. IPD Sharing Statement

Plan to Share IPD
No

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DenCT Shoulder Bone Quality Evaluation

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