Overview

This trial is active, not recruiting.

Condition osteoarthritis of the shoulder
Treatments pyrotitan, ascension orthopedics, inc., titan, ascension orthopedics, inc.
Sponsor Danderyd Hospital
Collaborator Ascension Orthopedics, Inc.
Start date January 2012
End date January 2017
Trial size 80 participants
Trial identifier NCT01587560, PyroTITAN DS

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Patients receiving a shoulder surface replacement implant made of pyrocarbon (the PyroTITAN Humeral resurfacing Arthroplasty)
pyrotitan, ascension orthopedics, inc. TITAN, Ascension Orthopedics, Inc.
All patients will be operated on with a shoulder resurfacing implant. In one arm of the study, the patients will receive an implant made of pyrocarbon. In the second arm, the patients will receive an implant made of Cobalt-Chrome. Aside from the materials, the implant are of the same design.
titan, ascension orthopedics, inc.
(Active Comparator)
Patients receiving a shoulder surface replacement implant made of Cobalt-Chrome(CoCR) (the TITAN Humeral Resurfacing Arthroplasty)
pyrotitan, ascension orthopedics, inc. TITAN, Ascension Orthopedics, Inc.
All patients will be operated on with a shoulder resurfacing implant. In one arm of the study, the patients will receive an implant made of pyrocarbon. In the second arm, the patients will receive an implant made of Cobalt-Chrome. Aside from the materials, the implant are of the same design.
titan, ascension orthopedics, inc.

Primary Outcomes

Measure
Fixation to bone as measured with radiostereometric analysis (RSA)
time frame: 24 months

Secondary Outcomes

Measure
Clinical results after surgery as measured with EuroQol-5D(EQ-5D), American Shoulder and Elbow Surgeons Score(ASES), Constant score, and Western Ontario Osteoarthritis of the Shoulder index(WOOS)
time frame: 24-48 months

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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 information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Danderyd Hospital.