A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant

Danderyd Hospital

Status: Unknown

Conditions: Osteoarthritis of the Shoulder

Treatments: Device: TITAN, Ascension Orthopedics, Inc.; Device: PyroTITAN, Ascension Orthopedics, Inc.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01587560

PyroTITAN DS

Details and patient eligibility

About

The purpose of the study is to investigate fixation to bone and the clinical results following shoulder resurfacing arthroplasty. The study will compare results between an implant made of Cobalt-Chrome(CoCr) and an implant made in pyrocarbon.

Enrollment: 80 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary or secondary osteoarthritis of the shoulder
• Age 40-75 years
• Patient capable of giving informed consent
• Patient agrees to comply with the study plan

Exclusion criteria

• Destruction of the proximal humerus
• Insufficient bone stock
• Deficient rotator cuff or earlier failed surgery of the rotator cuff
• Large muscle defects or insufficient blood supply in the affected arm
• Neuromuscular disorders
• Infection, untreated malignancy or transmittable disease preventing the patient from fulfilling the study
• Patient unwilling to comply with study regulations
• Patient with earlier allergic reaction to pyrocarbon
• Patient with known metastatic disease
• Patient who has been treated with more than 10 mg corticosteroids (e.g. Prednisone) daily within 3 months from surgery.
• Patient participating in other clinical study
• Patient in need of glenoid replacement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Pyrocarbon

Active Comparator group

Description:

Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty)

Treatment:

Device: PyroTITAN, Ascension Orthopedics, Inc.

Device: TITAN, Ascension Orthopedics, Inc.

CoCr

Active Comparator group

Description:

Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty)

Treatment:

Device: PyroTITAN, Ascension Orthopedics, Inc.

Device: TITAN, Ascension Orthopedics, Inc.

Sponsors of this trial

Lead Sponsor

Danderyd Hospital

Collaborating Sponsors

Ascension Orthopedics

Karolinska Institute

Swedish Shoulder and Elbow Arthroplasty Register