Health TrialsbyHealthPanel

DenCT Shoulder Bone Quality Evaluation

ConditionsOsteoarthritis ShoulderRotator Cuff Tears
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZimmer Biomet

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Non-inflammatory degenerative joint disease including osteoarthritis.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Preoperative CT Scan

    Radiation

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Shoulder ArthroplastyOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Immediate post-op
2

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.

Time frame
Intra-op
3

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.

Time frame
Intra-op
4

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.

Time frame
Intra-op

Secondary outcomes

Other outcomes

1

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.

Time frame
Pre-op

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zimmer Biomet

Lead sponsor

Zimmer, GmbH

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: