Total Knee Replacement With Duracon® and Vanguard™ Prostheses

• Sponsor: Biomet Orthopedics, LLC (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00588887
• Collaborator: New Lexington Clinic (Other)
• Enrollment: 150
• Location: 1
• Duration (Months): 36
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

The purpose of this study is to compare range of motion, Knee Society Scores, and duration of surgery for different total knee prostheses.

Condition or Disease	Intervention/Treatment	Phase
Degenerative Arthritis; Osteoarthritis; Rheumatoid Arthritis; Knee Arthritis	Device: Duracon®; Device: Vanguard™

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: Jun 1, 2005
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1	Device: Duracon®; This group utilizes the Duracon® prostheses for total knee replacement.
2	Device: Vanguard™; This group will utilize the Vanguard™ prostheses for total knee replacement.

Outcome Measures

Primary Outcome Measures

1. Range of motion, Knee Society Score, Duration of surgery [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.

• Patients requiring correction of varus, valgus, or posttraumatic deformity.

• Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Exclusion Criteria:

• Patients with infection, sepsis, or osteomyelitis.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biomet Orthopedics, Inc.	Warsaw	Indiana	United States	46581

Sponsors and Collaborators

• Biomet Orthopedics, LLC
• New Lexington Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biomet Orthopedics, LLC
• ClinicalTrials.gov Identifier: NCT00588887
• Other Study ID Numbers: 105-U-014
• First Posted: Jan 9, 2008
• Last Update Posted: Jun 21, 2017
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Arthritis; Osteoarthritis

Study Results

No Results Posted as of Jun 21, 2017