Do We Need Computer Assistance To Improve the Survival of Primary Total Knee Arthroplasty. A Minimum Ten Years Follow-up

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2011-12-31

Brief Summary

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The investigators asked: (1) Do computer-assisted total knee arthroplasty (TKAs) provide better alignment and clinical function? (2) Do computer-assisted TKAs provide better survivorship of implants and less complication? and (3) Do correction of the mechanical axis of the lower limb to within 3° of neutral is a prognostic marker for late revision surgery due to aseptic loosening?

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Detailed Description

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Computer-assisted total knee arthroplasty (TKA) is reported to improve the overall accuracy of positioning of the femoral and tibia components. However, an acceptable target for alignment remains a matter for debate. A mechanical axis within 3° of neutral axis has been used as the primary outcome measure in many clinical trials comparing computer-assisted- and conventional TKA. However, the evidence supporting this arbitrary value is unreliable because previous reports are limited by their small sample size, inadequate radiographs, short follow-up and lack of clarity when defining a margin of accuracy.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Non-Computer Assistance TKA

Group Type ACTIVE_COMPARATOR

Non-Computer Assistance TKA

Intervention Type PROCEDURE

Non-Computer Assistance Total Knee Arthroplasty

Computer Assistance TKA

Group Type EXPERIMENTAL

Computer Assistance TKA

Intervention Type PROCEDURE

Computer Assistance Total Knee Arthroplasty

Interventions

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Non-Computer Assistance TKA

Non-Computer Assistance Total Knee Arthroplasty

Intervention Type PROCEDURE

Computer Assistance TKA

Computer Assistance Total Knee Arthroplasty

Intervention Type PROCEDURE

Other Intervention Names

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Non-Computer Assistance Total Knee Arthroplasty Computer Assistance Total Knee Arthroplasty

Eligibility Criteria

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Inclusion Criteria

* End stage osteoarthritis of the knee joint who require total knee arthroplasty with bilateral lesions.

Exclusion Criteria

* Inflammatory disease
* patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery

Minimum Eligible Age

49 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No