Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement

NCT00743717 | Completed Phase 2 Results

• 1 other identifier: G010204
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery. The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.

Conditions

Knee Osteoarthritis

Keywords

total knee arthroplasty; osteoarthritis; ceramic bearing; zirconia

Outcome Measures

Primary Outcomes (1)

• Knee Score at 2 Years Post Operation

  The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) \> 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score \> 80 was used as a criterion to assess "success".

  within 2 years

Study Arms (2)

1

EXPERIMENTAL

Device: zirconia femoral component

2

ACTIVE COMPARATOR

Device: cobalt chrome femoral component

Interventions

zirconia femoral component DEVICE

total knee arthroplasty performed using implant with zirconia femoral component

1

cobalt chrome femoral component DEVICE

total knee arthroplasty performed using implant with cobalt chrome femoral component

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Skeletally mature
• Primary TKA for osteoarthritis or post-traumatic arthritis of the knee joint
• Stable or reconstructable collateral and posterior cruciate ligaments
• Correctable deformity
• Intact quadriceps and hamstrings mechanisms
• Patella bone thick enough (at least 15 mm) after resection

You may not qualify if:

• Previous TKA
• Bilateral knee arthritis
• Non-availability for follow-up
• Mental incompetence or confinement
• Patients being treated with other investigational devices for same disorder
• Infection
• Osteoporosis, acute renal failure, or other disorders known to affect bone quality
• Charcot's or Paget's disease
• Patient physical condition preventing use of appropriate size implant
• Disease conditions affecting blood supply to knee
• Insufficient bone quality or quantity
• Physical condition predisposing implant to extreme loads
• History of septic knee arthritis
• History of drug abuse

Sponsors & Collaborators

• Kinamed Incorporated: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Perry Secor
• Organization: Los Alamitos Orthopaedic Group

vsarin@kinamed.com

805-384-2748

Study Officials

• Vineet Sarin, PhD

  Kinamed Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2008
• First Posted: August 29, 2008
• Study Start: February 1, 2004
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 27, 2013
• Results First Posted: May 22, 2013

Record last verified: 2013-05