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Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty

S

St. Helena Hospital Coon Joint Replacement Institute

Status

Active, not recruiting

Conditions

Osteoarthritis

Treatments

Device: Robotic-arm assisted medical MCK implant

Study type

Observational

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay Unicompartmental knee arthroplasty implants at two, five and tem year follow up.

Full description

The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay unicompartmental knee arthroplasty implants at two, five, and ten year follow up. Study participants will also be asked about their level of satisfaction with their knee function following their robotic-arm assisted Unicompartmental Arthroplasty.

Enrollment

133 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients over 21 years of age who underwent primary robotic-arm assisted unicompartmental arthroplasty and received a medial MCK onlay implant and are at least 24 months post-operative.
  • Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written consent, patient has verbally consented to study participations.
  • Patient willing to comply with follow up.

Exclusion criteria

  • Patient will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health related quality of life forms.
  • Patient had active infection
  • Medial MCK onlay 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 contacts and locations

1

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Data sourced from clinicaltrials.gov

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