TITAN™ Reverse Shoulder System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2023-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the affected shoulder. The purpose of this study is to assess the short, mid and long term outcomes of the TITAN™ Reverse Shoulder System.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Evaluation of the Integra® Titan™ Modular Shoulder System Generation 2.5 for Primary Shoulder Joint Replacement

NCT03250767

Osteo Arthritis Shoulders Traumatic Arthritis Rheumatoid Arthritis

TERMINATED

MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

NCT04003272

Shoulder Pain Shoulder Injuries Shoulder Fractures +2 more

ENROLLING_BY_INVITATION

Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System

NCT01480440

Osteoarthritis Rheumatoid Arthritis Post-traumatic Arthritis +5 more

ACTIVE_NOT_RECRUITING

A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

NCT04089371

Arthroplasty Hemiarthroplasty Shoulder Pain

TERMINATED

A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing

NCT02405208

Arthritis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis of the Shoulder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TITAN™ Reverse Shoulder System (TRS)

TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct.

TITAN™ Reverse Shoulder System (TRS)

Intervention Type DEVICE

All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TITAN™ Reverse Shoulder System (TRS)

All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects with grossly deficient rotator cuff with severe arthropathy or Subjects with failed joint replacement with grossly deficient rotator cuff
* Subjects with a shoulder joint anatomically and structurally suited to receive the device
* Subjects at least 21 years of age and skeletally mature at the time of surgery
* Subject provided consent to participate in the clinical study (having signed the Informed Consent Form)

Exclusion Criteria

* Subjects without a functional deltoid muscle
* Subjects with active local or systemic infection
* Subjects with inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
* Subjects with poor bone quality such as osteoporosis where there could be considerable migration of the prosthesis and/or a chance of fracture of the humerus or glenoid
* Subjects with muscular, neurologic, or vascular deficiencies that compromise the affected extremity
* Subjects with known metal allergies
* Subjects are known to be at risk for lost to follow-up, or failure to return for scheduled visits
* Subjects who are prisoners
* Female subject who are pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No