A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant

NCT01587560 | Unknown DMC

• 1 other identifier: PyroTITAN DS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis of the Shoulder

Keywords

Shoulder; Arthroplasty; Pyrocarbon; Randomized controlled trial; Shoulder resurfacing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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)

  24-48 months

Study Arms (2)

Pyrocarbon

ACTIVE COMPARATOR

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

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

CoCr

ACTIVE COMPARATOR

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

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

Interventions

PyroTITAN, Ascension Orthopedics, Inc. DEVICE

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.

Also known as: TITAN, Ascension Orthopedics, Inc.

CoCr; Pyrocarbon

TITAN, Ascension Orthopedics, Inc. DEVICE

CoCr; Pyrocarbon

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danderyd Hospital: lead
• Ascension Orthopedics, Inc.: collaborator
• Swedish Shoulder and Elbow Arthroplasty Register: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Orthopaedic department, Danderyd Hospital

Stockholm, Stockholm County, 18288, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of research, Orthopedic dept.

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: April 30, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2018
• Last Updated: August 30, 2016

Record last verified: 2016-08

Locations

SE (1)