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Survivorship and Outcomes of Robotic-Arm Assisted Bicompartmental Arthroplasty

S

St. Helena Hospital Coon Joint Replacement Institute

Status

Active, not recruiting

Conditions

Osteoarthritis

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

The purpose of the study is to determine the clinical outcomes and survivorship of robotic-arm assisted medial bicompartmental knee arthroplasty at two, five, seven and ten years postoperative.

Full description

The purpose of the study is to determine the survivorship, patient satisfaction and clinical outcomes of robotic-arm assisted medial bicompartmental knee arthroplasty using the MCK implant system starting at two years post-operative and continuing for five, seven and ten years post-operative.

Enrollment

50 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients over 21 years of age who underwent robotic-arm assisted medial bicompartmental arthroplasty by the investigating surgeon and received MCK implants and are at least 24 months post-operative.
  • Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written signed consent, patient has verbally consented to study participation.
  • Patient is willing to comply with follow up

Exclusion criteria

  • Patients will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health quality of life forms.
  • Patient had active infection
  • Implants were implanted without bone cement
  • Patients did not have sufficient bone stock to allow for insertion and fixation of components
  • Patient did not have sufficient soft tissue integrity to allow for stability
  • Patient had a neurological or muscular deformity that did not allow for control of the knee.

Trial design

50 participants in 1 patient group

Medial Bicompartmental Knee Arthroplasty
Description:
Patient who have received a robotic-arm assisted medial and patellofemoral knee arthroplasty.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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