NCT01480453

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2011

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

8 years

First QC Date

November 23, 2011

Last Update Submit

March 22, 2019

Conditions

OsteoarthritisRheumatoid ArthritisPost-traumatic ArthritisUnunited Humeral Head FractureIrreducible 3- and 4-part Proximal Humeral FracturesAvascular Necrosis

Keywords

OsteoarthritisRheumatoid arthritisPost-traumatic arthritisUnunited humeral head fractureIrreducible 3- and 4-part proximal humeral fracturesAvascular necrosis

Outcome Measures

Primary Outcomes (1)

  • Survivorship

    Based on removal or intended removal of the device and determined using the Kaplan-Meier method.

    10 Years

Secondary Outcomes (1)

  • Pain and Functional Performance

    10 Years

Study Arms (1)

Trabecular Metal Humeral Stem

Patients requiring primary, total or hemi shoulder arthroplasty who receive the Trabecular Metal Humeral Stem.

Device: Trabecular Metal Humeral Stem

Interventions

Trabecular Metal Humeral StemDEVICE

Trabecular Metal Humeral Stem used in primary, total or hemi shoulder arthroplasty

Also known as: TM Humeral Stem, TM Humeral
Trabecular Metal Humeral Stem

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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;

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Norton Orthopaedic Specialists

Louisville, Kentucky, 40241, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

The Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

OsteoarthritisArthritis, RheumatoidOsteonecrosis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBone DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 28, 2011

Study Start

January 2, 2011

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

US(3)