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X-3 Polyethylene Survival Outcomes Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
Michael J. Stuart, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00493792
First received: June 26, 2007
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

A prospective, randomized, blinded clinical trial is proposed to compare Stryker Orthopaedics N2Vac Polyethylene to their X3 Polyethylene when used with the Triathlon Posterior Stabilized (PS) total knee system.


Condition Intervention Phase
Arthroplasty, Replacement, Knee
Total Knee Replacement
Device: Stryker X3 crosslink
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study Comparing the Survival for X-3 Polyethylene to N2Vac Polyethylene When Used With the Triathlon Posterior Stabilized (PS) Total Knee System.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • The primary efficacy parameter is the revision rate for total knee arthroplasty at 10 years post- surgery. [ Time Frame: 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Active flexion, Passive flexion, Active extension, and Passive extension ROM at the 2, 5, 7 and 10-year visits. [ Time Frame: 10 ] [ Designated as safety issue: No ]
  • KSS pain and motion scores at the 3 months, 2, 5, 7 and 10-year visit. [ Time Frame: 10 ] [ Designated as safety issue: Yes ]
  • SF-12 v1 scores at the 3 months, 2, 5, 7 and 10-year visit. [ Time Frame: 10 ] [ Designated as safety issue: No ]
  • Radiographic success/failure at the 3 months, 2, 5, 7 and 10-year visits. [ Time Frame: 10 ] [ Designated as safety issue: Yes ]
  • Radiographic failure is defined as a score of 10 or greater according to the Knee Society Rotenographic Scoring System, regardless of symptoms. [ Time Frame: 10 ] [ Designated as safety issue: Yes ]

Enrollment: 516
Study Start Date: February 2007
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Stryker Orthopaedics N2Vac Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty.
Device: Stryker X3 crosslink
Radiographs, questionnaires and an exam will be obtained at key post-surgical follow up dates. 3months, 2years, 5 years, 7 years and 10 years.
Other Name: Stryker X3
2
X3 Polyethylene when used with a Triathlon Posterior Stabilized total knee system. This is a fixed- bearing knee intended for use in patients undergoing cemented total knee arthroplasty.
Device: Stryker X3 crosslink
Radiographs, questionnaires and an exam will be obtained at key post-surgical follow up dates. 3months, 2years, 5 years, 7 years and 10 years.
Other Name: Stryker X3

Detailed Description:

This is a fixed-bearing knee intended for use in patients undergoing cemented total knee arthroplasty. The devices to be used are both FDA approved via 510k clearance.

A total of 572 cases (286 per group) will be entered. Each patient will be assessed pre-operatively and post-operatively at three months and two, five, seven and ten years. The primary endpoint will be the revision rate at ten years. The result for these will be analyzed using an unconditional test of equivalence between two independent binomials. Chi-square analysis will be used to compare the instance of mortality, revision surgery, deep vein thrombosis, pulmonary embolus, neurovascular complication, and infection. Other outcome measures incorporated in the Knee Society Clinical rating scale will undergo appropriate generalized linear regression for the type of outcome involved. The primary aim of the study is to compare the survivorship of two types of polyethylene (conventional N2Vac and highly cross-linked X3) used in a fixed-bearing total knee system in patients undergoing cemented total knee arthroplasty. These results will be measured through radiographs at each post-operative interval with an independent radiograph review being performed after all patients have reached 7 and 10 year follow-up. Secondary results will also be collected and will focus on disease-specific (Knee Society Scores), global (SF-12 v1), and outcome measures. Radiographic results consisting of standing anteroposterior, lateral and Merchant views of the surgical knee will be recorded and analyzed. Completion of the initial investigation will occur at the 10-year interval after the last enrolled.

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. Subjects willing to sign the informed consent.
  2. Subjects able to comply with follow-up requirements including post-operative weight bearing restrictions and self-evaluations.
  3. Male and non-pregnant female subjects ages 21-85 years of age at the time of surgery.
  4. Subjects requiring a primary total knee replacement.
  5. Subjects with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
  6. Subjects with intact collateral ligaments as determined by the surgeon investigator.

EXCLUSION CRITERIA:

  1. Subjects with inflammatory arthritis.
  2. Subjects with a history of total or unicompartmental reconstruction of the affected joint.
  3. Subjects that have had a high tibial osteotomy or femoral osteotomy.
  4. Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
  5. Subjects with a systemic or metabolic disorder leading to progressive bone deterioration.
  6. Subjects that are immunologically compromised, or receiving chronic steroids (>30 days).
  7. Subjects bone stock is compromised by disease or infection that cannot provide adequate support and/or fixation to the prosthesis.
  8. Subjects with knee fusion to the affected joint.
  9. Subjects with an active or suspected latent infection in or about the knee joint.
  10. Subjects that are prisoners.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00493792

Locations
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Stryker Orthopaedics
Investigators
Principal Investigator: Michael J. Stuart, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Michael J. Stuart, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00493792     History of Changes
Other Study ID Numbers: 06-003093, 06-003093
Study First Received: June 26, 2007
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014