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Status:

TERMINATED

Triathlon® Partial Knee Replacement (PKR) Outcomes Study

Lead Sponsor:

Stryker Orthopaedics

Conditions:

Arthroplasty, Replacement, Knee

Eligibility:

All Genders

21-75 years

Phase:

NA

Brief Summary

The purpose of this study is to compare the 10-year Knee Society Score (KSS) functional results of the Triathlon PKR Unicondylar Knee to the 10-year Knee Society Score (KSS) functional results of the ...

Eligibility Criteria

Inclusion

  • The subject is a male or non-pregnant female 21-75 years of age at the time of enrollment.
  • The subject requires a primary cemented unicompartmental knee replacement.
  • The subject has a diagnosis of osteoarthritis (OA) or posttraumatic arthritis (TA).
  • The subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present.
  • The subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion.
  • The subject's preoperative mechanical alignment is less than 15 degrees of varus and 15 degrees of valgus.
  • The subject has signed the Institutional Review Board (IRB) approved study specific Informed Patient Consent Form.
  • The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion

  • The subject has inflammatory arthritis or avascular necrosis(AVN).
  • The subject is obese, BMI \> 35.
  • The subject has a history of total or unicompartmental (contralateral compartment and/or patellofemoral joint) reconstruction of the affected joint.
  • The subject has a history of anterior cruciate ligament (ACL) reconstruction.
  • The subject has had a high distal femoral, or proximal tibial osteotomy.
  • The subject has a mental, neuromuscular or neurosensory disorder, which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in post-operative care and/or limit the ability to assess the performance of the device.
  • The subject has a systemic or metabolic disorder leading to progressive bone deterioration that the surgeon feels would affect the overall outcome of the study.
  • The subject is immunologically suppressed, or is receiving chronic steroids (\>30 days duration).
  • The subject has a known sensitivity to device materials.
  • The subject's bone stock is compromised by disease and/or infection which cannot provide adequate support and/or fixation to the prosthesis.
  • The subject's bone stock is compromised by a prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
  • The subject has an active or suspected latent infection in or about the knee joint.
  • The subject is a prisoner.

Key Trial Info

Start Date :

January 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2023

Estimated Enrollment :

111 Patients enrolled

Trial Details

Trial ID

NCT00966979

Start Date

January 1 2010

End Date

May 1 2023

Last Update

September 13 2023

Active Locations (9)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (9 locations)

1

Heekin Orthopaedic Institute for Research, Inc.

Jacksonville, Florida, United States, 32204

2

Rothman Institute

Egg Harbor, New Jersey, United States, 08234

3

Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital

Buffalo, New York, United States, 14203

4

Syracuse Orthopedic Specialists

Syracuse, New York, United States, 13214