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Completed

NCT Number: NCT02251522

A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Versus Off-the-Shelf

It has been noted that patients "dramatically overestimate their functional ability early after surgery." Despite use of assistive devices increasing and functional testing scores decreasing post-surgery, the patient reported outcome scores fail to show worsening. Outcome questionnaires will be administered and functional testing will be conducted on all patients to capture these changes.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vitos Orthopädische Klinik Kassel, Kassel, Germany

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About this study

The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities that the patients are familiar with.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Implant must be at least 6 months post-op and doing well
  • Patient has had a total CR knee implant
  • > 18 years of age

Exclusion criteria

  • Simultaneous bilateral procedure occurred
  • BMI > 40
  • Other physical disability that requires an aid for walking or disability affecting the hips, spine, contralateral knee or other joint that limits function
  • Participation in another clinical study which would confound results
  • Inability to complete the protocol in the opinion of the clinical staff due to safety or other reasons

Treatment and study plan

ConforMIS Total Knee Replacement System

Device

Total knee replacement system using a patient specific implant.

Off-the-Shelf Knee Replacement System

Device

Total knee replacement system not using a patient specific implant.

Primary outcomes

  1. Functional Outcome time differences between the two groups

    Time frame: at least 6 months post-op

    The study primary endpoint is to compare functional testing time between patients implanted with the iTotal implant verses the off-the-shelf implants

Secondary outcomes

  1. Outcomes questionnaire- Knee Society Score

    Time frame: At least 6 months post op

    Comparing different patient outcome scores between the two groups

  2. Outcomes questionnaire- KOOS

    Time frame: At least 6 months post op

    Comparing different patient outcome scores between the two groups

  3. Outcomes questionnaire- Forgotten Joint Score

    Time frame: At least 6 months post op

    Comparing different patient outcome scores between the two groups

Sponsors and collaborators

Lead sponsor

Restor3D

Industry

Registry information

Official study title

A Single Time-Point Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off-the-Shelf Replacement

Acronym: STEPS

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2014
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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