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

NCT01966848 | Unknown

• 1 other identifier: H-1-2013-086
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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.

Conditions

Osteoarthritis

Keywords

Knee; osteoarthritis; arthroplasty; tka; rsa

Outcome Measures

Primary Outcomes (1)

• To compare the Vanguard CR and Vanguard XP prosthesis regarding migration/rotation over time, measured by RSA

  Migration/rotation of the prosthesis measured in mm/degrees using RSA.

  2 years

Secondary Outcomes (1)

• To compare patient reported outcomes after treatment with a Vanguard CR or Vanguard XP prosthesis

  2 years

Study Arms (2)

Vanguard CR

ACTIVE COMPARATOR

Patients will receive the posterior cruciate retaining Vanguard CR prosthesis

Device: Wich prosthesis is used

Vanguard XP

ACTIVE COMPARATOR

Patients will receive the bi-cruciate retaining Vanguard xp prosthesis

Device: Wich prosthesis is used

Interventions

Wich prosthesis is used DEVICE

Vanguard CR; Vanguard XP

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Terminal illness.
• Rheumatoid arthritis.
• Prior open surgery on the affected knee.
• 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 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.

Hvidovre, Capital Region of Denmark, 2650, Denmark

Location

Related Publications (1)

• Troelsen A, Ingelsrud LH, Thomsen MG, Muharemovic O, Otte KS, Husted H. Are There Differences in Micromotion on Radiostereometric Analysis Between Bicruciate and Cruciate-retaining Designs in TKA? A Randomized Controlled Trial. Clin Orthop Relat Res. 2020 Sep;478(9):2045-2053. doi: 10.1097/CORR.0000000000001077.

  PMID: 32023233 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 22, 2013
• Study Start: November 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2024
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

DK (1)