Polyethylene Wear Study on the Triathlon Total Knee Prosthesis

NCT02525588 | Completed Results

• 1 other identifier: K-S-039
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of conventional UHMWPE (ultra-high-molecular-weight polyethylene) with highly cross-linked polyethylene (X3) in a condylar stabilizing (CS) fixed bearing total knee prosthesis by means of RSA and clinical evaluation.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Assessment of Polyethylene Inlay Wear by Roentgen Stereophotogrammetric Analysis (RSA).

  RSA is a highly accurate technique for the assessment of three-dimensional migration and micro motion of a joint replacement prosthesis relative to the bone it is attached to. Because of the high accuracy, RSA can also be used to measure wear in knee replacements and is used in this study for the assessment of the wear of the two polyethylene inlay types N2Vac polyethylene and X3 polyethylene.

  1, 2 and 5 years follow-up

Secondary Outcomes (5)

• Assessment of Prosthetic Migration Results After Two Years by RSA.

  3 and 6 months,1, 2 and 5 years follow-up

• Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)

  Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

• Investigation of Clinical Performance and Patient Outcome With the Short Form Patient Questionnaire (SF-36)

  Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

• Investigation of Clinical Performance and Patient Outcome With the EuroQuol - 5 Dimension (EQ-5D) Patient Questionnaire

  Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

• Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire

  Pre-operative, 6 weeks, 3 and 6 months, 1, 2 and 5 years

Study Arms (2)

Conventional polyethylene inlay nitrogen/vacuum-packed (N2Vac)

ACTIVE COMPARATOR

Conventional UHMWPE inlay in a Triathlon Condyle Stabilizing (CS) fixed bearing total knee prosthesis

Device: Triathlon CS fixed bearing total knee prosthesis

Highly cross-linked polyethylene (X3)

ACTIVE COMPARATOR

X3 highly cross-linked polyethylene inlay in a Triathlon CS fixed bearing total knee prosthesis

Device: Triathlon CS fixed bearing total knee prosthesis

Interventions

Triathlon CS fixed bearing total knee prosthesis DEVICE

The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.

Conventional polyethylene inlay nitrogen/vacuum-packed (N2Vac); Highly cross-linked polyethylene (X3)

Eligibility Criteria

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

You may qualify if:

• Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
• Patients with a pre-operative knee score of \< 70.
• Patients scheduled to undergo primary total knee replacement with any of the following indication.
• Painful and disabled knee joint resulting from osteoarthritis.
• One or more compartments are involved.
• Need to obtain pain relief and improve function.
• Ability and willingness to follow instructions, including control of weight and activity level, and to return for follow-up evaluations.
• A good nutritional state of the patient.
• Full skeletal maturity of the patient, patients who are at least 18 years of age.
• Patients of either sex.

You may not qualify if:

• The subject is morbidly obese, defined as Body Mass Index (BMI) of \> 40.
• Skeletal immaturity of the patient, patients who are less than 18 years of age.
• Patient has a flexion contracture of 15° and more.
• Patient has a varus/valgus contracture of 15° and more.
• Patients with a pre-operative knee score of \>70.
• The subject has a history of total or unicompartmental reconstruction of the affected joint.
• The subject will be operated bilaterally.
• Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA \> 1 year ago with good outcome can be included in the study).
• Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA \> 6 months ago with good outcome can be included in the study).
• The subject has an active or suspected latent infection in or about the knee joint.
• Osteomyelitis.
• Sepsis.
• Patients who will need lower limb joint replacement for another joint within one year.
• The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
• The subject has a systemic or metabolic disorder leading to progressive bone deterioration.

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (1)

Department of Orthopaedics 't Langeland Ziekenhuis Zoetermeer

Zoetermeer, South Holland, 2725 NA, Netherlands

Location

Results Point of Contact

• Title: Britta von den Brincken, Clinical Study Manager
• Organization: Stryker

britta.vondenbrincken@stryker.com

+491638999202

Study Officials

• H. Kaptijn, MD

  't Langeland Ziekenhuis Zoetermeer

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: August 17, 2015
• Study Start: September 1, 2011
• Primary Completion: March 28, 2019
• Study Completion: March 28, 2019
• Last Updated: February 22, 2024
• Results First Posted: April 7, 2020

Record last verified: 2024-02

Locations

NL (1)