A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant

Osteoarthritis of the Shoulder Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01587560
• Other study ID #: PyroTITAN DS
• Status: Active, not recruiting
• Phase: N/A
• First received: February 17, 2012
• Last updated: August 29, 2016
• Start date: January 2012
• Est. completion date: January 2018

Study information

• Verified date: August 2016
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Shoulder

Intervention

Device:
• PyroTITAN, 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.

Locations

Country	Name	City	State
Sweden	Orthopaedic department, Danderyd Hospital	Stockholm

Sponsors (4)

Lead Sponsor	Collaborator
Danderyd Hospital	Ascension Orthopedics, Inc., Karolinska Institutet, Swedish Shoulder and Elbow Arthroplasty Register

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fixation to bone as measured with radiostereometric analysis (RSA)	Early migration of the implants will be measured with RSA at 3, 6, 12 and 24 months.	24 months	No
Secondary	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)	Outcome after surgery will be evaluated using the above mentioned scores performed by and independent and blinded investigator.	24-48 months	No