Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties. A Trial Evaluating Early Component Migration by RSA and Patient Reported Outcome.

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Hvidovre University Hospital
Sponsor:
Collaborator:
Biomet (Warsaw, Indiana, USA)
Information provided by (Responsible Party):
Morten Grove Thomsen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01966848
First received: October 16, 2013
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

In the history of TKA several different types of prosthetic designs have been evolved in order to optimize knee function after total knee replacement. The most common difference between the prosthetic designs revolves around issues concerning the preservation of the cruciate ligaments. The most popular prostheses have been the posterior stabilized prosthesis (PS) in which both cruciate ligaments are resected and the posterior cruciate retaining prosthesis (CR) in which only ACL is resected and PCL is preserved. Both these prosthetic designs have shown excellent clinical results in the literature.

In the knee the role of the cruciate ligaments is to insure anterior/posterior stability, but studies have also shown, that the cruciate ligaments contain proprioceptive mechanisms which control joint kinematics essential for accurate knee function. One could therefore imagine that a prosthetic design that preserves both cruciate ligaments would be superior to prosthetic designs in which ACL or ACL/PCL is resected in achieving good clinical results and patient satisfaction.

Only a few prosthetic designs, which preserve both cruciate ligaments, have been available to the market. However studies based on fluoroscopic assays and gait analysis has shown that this prosthetic design is superior to cruciate sacrificing designs in preserving normal knee kinematics during activities of daily living after TKA. Studies, in which patients have received two different types of prosthesis in each knee, have also shown that bi-cruciate retaining TKA's is preferred, when compared to more constrained prosthetic designs.

The new Vanguard XP TKA system (Biomet®, Warsaw, Indiana, USA) is a further development of the Vanguard TKA system, which has shown good clinical results in earlier studies. With the new Vanguard XP system both cruciate ligaments are preserved. In theory this should result in a more natural feeling of the knee because the stability and proprioceptive signals from both cruciate ligaments are preserved. In order to investigate the potential benefits of this new prosthetic design, the clinical and radiological results of knees receiving a Vanguard XP and Vanguard CR prostheses are compared.

In this study we wish to investigate:

  1. If the use of the Vanguard XP prosthesis will influence the migration of the femur- and tibial components measured by Radiostereometric Analysis (RSA) when compared to the Vanguard CR prosthesis.
  2. If the use of the Vanguard XP prosthesis will result in increased participant knee function, satisfaction and quality of life when compared to the Vanguard CR prosthesis.
  3. If the use of the Vanguard XP prosthesis will influence radiologic signs of osteolysis, complication rates and revision rates when compared to the Vanguard CR prosthesis.

This project is carried out as a randomized controlled double-blinded trial, in which the clinical and radiological outcomes after treatment of knee osteoarthritis with insertion of either a Vanguard XP or Vanguard CR prosthesis is compared.


Condition Intervention
Osteoarthritis
Device: Wich prosthesis is used

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties. A Randomized Controlled Trial Evaluating Early Component Migration by RSA and Patient Reported Outcome.

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • To compare the Vanguard CR and Vanguard XP prosthesis regarding migration/rotation over time, measured by RSA [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Migration/rotation of the prosthesis measured in mm/degrees using RSA.


Secondary Outcome Measures:
  • To compare patient reported outcomes after treatment with a Vanguard CR or Vanguard XP prosthesis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Pain (VAS-scale) Satisfaction (VAS-scale) OKS (Oxford knee score) questionnaire FJS (Forgotten Joint Score) questionnaire


Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vanguard CR Device: Wich prosthesis is used
Active Comparator: Vanguard XP Device: Wich prosthesis is used

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary knee osteoarthritis set to receive a primary unilateral cemented total knee arthroplasty at Copenhagen University Hospital Hvidovre.
  • Participants must be >18 years of age.
  • Participants must be able to speak and understand Danish.
  • Participants must be able to give informed consent and be cognitively intact.
  • Participants must be expected to be able to complete all postoperative controls.
  • Participants must not have severe comorbidities, ASA-score ≤ 3.

Exclusion Criteria:

  • Terminal illness.
  • Rheumatoid arthritis.
  • Prior open surgery on the affected knee.
  • Prior arthroscopic surgery with surgery on anterior and/or posterior cruciate ligament (meniscal surgery only does not lead to exclusion).
  • Prior high-energy trauma to the affected knee.
  • Prior history of anterior and/or posterior cruciate ligament rupture.
  • Suspicion of anterior and/or posterior cruciate ligament rupture at clinical examination.
  • Documented osteoporosis with patient in active medical treatment.
  • Comorbidity with altered pain perception (e.g. DM with neuropathy).
  • Participants that develop deep infection in the follow-up period are excluded from the study.

Regarding RSA assays

• Participants with less than 3 Tantalum beads visible around the Femur- or Tibia component on RSA assays are excluded from the migration measurements. Data regarding secondary objectives from these subjects will be included.

Regarding intraoperative exclusion • If the anterior and/or posterior cruciate ligaments are found missing or totally ruptured at direct intraoperative visualization, patients excluded at this point and will receive the department's standard prosthesis (Vanguard CR if posterior cruciate ligament is intact).

Regarding contraception

• Patients who receive knee prosthesis have most often reached the non-fertile age (50+). In the case that a fertile woman participates in the study it will be ensured that she is not pregnant.

  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: NCT01966848

Locations
Denmark
Dept. of Orthopedics, University Hospital of Hvidovre, Denmark. Recruiting
Hvidovre, Capital Region of Denmark, Denmark, 2650
Contact: Morten G Thomsen, MD       morten@grovethomsen.dk   
Principal Investigator: Morten G Thomsen, MD         
Sponsors and Collaborators
Hvidovre University Hospital
Biomet (Warsaw, Indiana, USA)
  More Information

No publications provided

Responsible Party: Morten Grove Thomsen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01966848     History of Changes
Other Study ID Numbers: H-1-2013-086
Study First Received: October 16, 2013
Last Updated: January 22, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Keywords provided by Hvidovre University Hospital:
Knee
osteoarthritis
arthroplasty
tka
rsa

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014