Impact of Component Design and Fixation in Total Knee Arthroplasty

NCT03272178 | Completed FDA Device

• 1 other identifier: 201708094
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine implant design and determine if method of fixation cemented versus cementless results in different bone loss patterns. The investigators also want to determine if clinical outcomes correlate with bone density changes.

Conditions

Arthroplasties, Knee Replacement

Outcome Measures

Primary Outcomes (1)

• Change in bone density

  Patients will have a DEXA scan to look for change in bone loss at 6 weeks, 1 year, and 2 year to determine bone loss patterns and geometry

  2 years

Secondary Outcomes (6)

• knee society score

  2 years

• Forgotten joint score

  2 years

• Oxford knee score

  2 years

• UCLA Activity score

  2 years

• SF-12

  2 years

Study Arms (2)

Triathlon knee total knee arthroplasty

50 Patients who are assigned to Triathlon knee, half cemented/half cementless

Device: Triathlon total knee implant

Depuy knee total knee arthroplasty

50 Patients who are assigned to Depuy knee, half cemented/half cementless

Device: Depuy total knee implant

Interventions

Depuy total knee implant DEVICE

patients from Dr Nunley's clinic will get a Depuy implant

Depuy knee total knee arthroplasty

Triathlon total knee implant DEVICE

patients from Dr Barrack's clinic will get a Triathlon implant

Triathlon knee total knee arthroplasty

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A. Patients who qualify for a Primary Total Knee Arthroplasty using Stryker Triathlon Implant(thin tray) or Depuy Attune(thick tray) Implant

You may qualify if:

• Patients who qualify for a Primary Total knee using Triathlon Implant(thin tray) or Depuy Attune(thick tray) Implant
• years of age
• Willing to sign informed consent
• Willing to return for all follow-up visits

You may not qualify if:

• Patients with inflammatory arthritis
• BMI \> 40
• Patient with an active infection or suspected infection in the joint
• Patient who have undergone osteotomy
• Patients who have a previous diagnosis of osteopenia/osteoporosis or patients with weak bones and/or currently on medications to increase bone density/who have poor bone quality
• Patients who have had previous patella fracture or surgery
• Patients who have had previous knee or hip replacement surgery on the ipsilateral side
• Patients who require patellar resurfacing
• Patient with major medical/muscular/orthopedic deformities
• Unable to undergo DEXA scanning.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Stryker Nordic: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: September 5, 2017
• Study Start: November 20, 2017
• Primary Completion: November 15, 2021
• Study Completion: November 15, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

US (1)