Outcomes Study of the TM Humeral Stem Used in Primary, Total or Hemi Shoulder Arthroplasty

An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis
What is being tested?: Trabecular Metal Humeral Stem
Type of treatment: Medical device
How many people: 67 participants
Where: 3 sitesUnited States
Study dates: 2 Jan 2011to 31 Dec 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Each investigator will screen from his/her patients who suffer from Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis who meet the inclusion/exclusion criteria stated in the protocol.

Who may be able to join

Patient is >18 years of age;
Patient is skeletally mature;
Patient qualifies for primary unilateral or bilateral total or hemi shoulder arthroplasty based on physical exam and medical history including the following: Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis
Patient is willing and able to provide written informed consent;
Patient is willing and able to cooperate in the required post-operative therapy;
Patient is will and able to complete scheduled follow-up evaluations/questionnaires as described in the Informed Consent;
Patient has participated in the Informed Consent process and has signed the IRB/ERB approved informed consent;

Who cannot join

The patient is a prisoner;
The patient is mentally incompetent or unable to understand what participation in the study entails;
The patient is a known alcohol or drug abuser;
The patient is anticipated to be non-compliant;
The patient has one of the following compromising the affected limb; a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable;
The patient has a local/systemic infection;

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The patient is known to be pregnant;
The patient has marked bone loss;
The patient has a known sensitivity or allergic reaction to one or more of the implanted materials;
The patient is unwilling or unable to give consent or to comply with the follow-up program.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Norton Orthopaedic Specialists
Louisville, Kentucky, 40241
The Rothman Institute
Philadelphia, Pennsylvania, 19107
William Beaumont Hospital
Royal Oak, Michigan, 48073

Other trials in United States

About this study

Official title: Retrospective and Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Humeral Stem

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.

Read the detailed description

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Humeral Stem.

Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular Metal Humeral Stem.

Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the SF-12 as well as AEs and radiographic parameters by analysis of x-rays.

Conditions: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture, Irreducible 3- and 4-part Proximal Humeral Fractures, Avascular Necrosis
Being tested: Trabecular Metal Humeral Stem
Keywords: Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis
Medical subject headings: Osteoarthritis, Arthritis, Rheumatoid, Osteonecrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trabecular Metal Humeral StemDevice
Also called TM Humeral Stem, TM Humeral
Trabecular Metal Humeral Stem used in primary, total or hemi shoulder arthroplasty

Study groups in NCT01480453
Study group	Role	What they receive
Trabecular Metal Humeral Stem		Patients requiring primary, total or hemi shoulder arthroplasty who receive the Trabecular Metal Humeral Stem. Receives: Device: Trabecular Metal Humeral Stem

What is being measured

The primary outcome is the main question the study is designed to answer.

Survivorship
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Measured: 10 Years

Secondary outcomes (1)

Pain and Functional Performance
Measurements will be based on the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE)
Measured: 10 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jan 201131 Dec 2018

First posted28 Nov 2011 (estimated)
Study start2 Jan 2011
Primary completion31 Dec 2018
Study completion31 Dec 2018

Why it stopped: Business decision was made to remove the CE mark from this product, thus prompting the closing of this study.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by Zimmer BiometThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01480453
Sponsor's protocol ID: CMU2010-29E
Status last verified: Mar 2019
First submitted: 23 Nov 2011
Last updated: 26 Mar 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Retrospective and Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Humeral Stem
ClinicalTrials.gov ID: NCT01480453
Acronym / sponsor ID: CMU2010-29E
Conditions: Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture, Irreducible 3- and 4-part Proximal Humeral Fractures, Avascular Necrosis
Keywords: Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis
Study type: Observational
Recruitment status: TerminatedReason stopped: Business decision was made to remove the CE mark from this product, thus prompting the closing of this study.
Enrolment: 67 participants (actual)
Lead sponsor: Zimmer BiometIndustry (pharma, biotech, devices)
Study start: 2 Jan 2011 (actual)
Primary completion: 31 Dec 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 28 Nov 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Trabecular Metal Humeral Stem	–	Device: Trabecular Metal Humeral StemPatients requiring primary, total or hemi shoulder arthroplasty who receive the Trabecular Metal Humeral Stem.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Each investigator will screen from his/her patients who suffer from Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis who meet the inclusion/exclusion criteria stated in the protocol.

Key inclusion criteria (7 listed)

Patient is >18 years of age;
Patient is skeletally mature;
Patient qualifies for primary unilateral or bilateral total or hemi shoulder arthroplasty based on physical exam and medical history including the following: Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Ununited humeral head fracture, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis
Patient is willing and able to provide written informed consent;
Patient is willing and able to cooperate in the required post-operative therapy;

Key exclusion criteria (10 listed)

The patient is a prisoner;
The patient is mentally incompetent or unable to understand what participation in the study entails;
The patient is a known alcohol or drug abuser;
The patient is anticipated to be non-compliant;
The patient has one of the following compromising the affected limb; a significant injury to the upper brachial plexus, paralysis of the axillary nerve or a neuromuscular disease compromising the affected limb which would render the procedure unjustifiable;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trabecular Metal Humeral StemAlso: TM Humeral Stem, TM HumeralTrabecular Metal Humeral Stem used in primary, total or hemi shoulder arthroplasty	Device	Trabecular Metal Humeral Stem

Primary outcome

Survivorship
Time frame: 10 Years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

1 secondary outcome

Pain and Functional Performance
Time frame: 10 Years

Results and safety

The study was stopped early (reason given: Business decision was made to remove the CE mark from this product, thus prompting the closing of this study.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
Individual participant dataSharing planned: Undecided

Related trials for Osteoarthritis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis and Rheumatoid Arthritis, run by Zimmer Biomet at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survivorship (time frame: 10 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01480453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.