TKA Operating Room Efficiency for TKA Using Customized Implant Techniques

NCT ID: NCT04180423

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-28

Study Completion Date

2022-09-19

Brief Summary

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This is a multi-centered prospective, consecutively enrolled study that will be conducted in the United States. Surgeons that are new users of the iTotal Knee system (defined by no experience using the customized Total Knee Replacement (TKR) in the last 6 months) will be involved in the study. To complete the study protocol, the center will collect baseline surgical and training data on 10 "off-the-shelf" TKR patients using the implant system the surgeon currently uses. Then the first 50 consecutive patients who have been identified to receive the iTotal implant (Cruciate-Retaining or Posterior-Stabilizing) based on patient factors and the implant system IFU will be enrolled in the study. Simultaneous bilateral Total Knee Arthroplasty cases will be excluded.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Off-the-Shelf Total Knee Arthroplasty Patients

Off-the-Shelf Implant Total Knee Replacement

Intervention Type DEVICE

Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Off-the-Shelf implants use standard sizing.

Conformis iTotal Total Knee Arthroplasty Patients

Customized Implant Total Knee Replacement

Intervention Type DEVICE

Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Customized implants are customized individually made knee implants which are designed specific to each patient's unique anatomy.

Interventions

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Off-the-Shelf Implant Total Knee Replacement

Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Off-the-Shelf implants use standard sizing.

Intervention Type DEVICE

Customized Implant Total Knee Replacement

Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Customized implants are customized individually made knee implants which are designed specific to each patient's unique anatomy.

Intervention Type DEVICE

Other Intervention Names

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Conformis iTotal

Eligibility Criteria

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Inclusion Criteria

* \> 18 years of age

Exclusion Criteria

* 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
* Simultaneous bilateral Total Knee Arthroplasty cases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Restor3D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kettering Medical Center

Kettering, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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19-002i

Identifier Type: -

Identifier Source: org_study_id

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