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Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty

NCT ID: NCT02993016

Last Updated: 2016-12-14

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-12-31

Brief Summary

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Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving function. However, in instances where incorrect positioning and malignment of the TKA components are observed, patients can experience a range of negative postoperative outcomes such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant loosening, and eventual early revision. To avoid these complications, achieving a postoperative alignment within the range of 0°±3° of the mechanical axis is recommended. Manual intramedullary/extramedullary guides are not thought to be capable of consistently achieving axes in this range, and though computer-assisted navigation has shown superior results in comparison with conventional instrumentation, it is also limited by increased surgical times and no clear superiority in improving short-term clinical outcomes. Thus, there has been in a push in the orthopaedic community to create more precise technologies to aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation (PSI), which uses anatomical data obtained primarily from pre-operative axial computed tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs individualized to the patient's unique anatomy, was created with this goal.

This study aims to compare the clinical results of conventional and patient-specific instruments in total knee arthroplasty.

Detailed Description

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The objective of this work was to compare pain, stiffness, function and accuracy between groups at minimum 2 year postoperatively. The investigators hypothesized that PSI would lead to a neutral mechanical axis on average more frequently than conventional instrumentation.

The study design is a double-blind randomized controlled trial. Randomly, fifty patients planed to undergo total knee arthroplasty using conventional instruments and other fifty patients undergo total knee arthroplasty using patient-specific instruments. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index) pain scale (preoperative and postoperative 6, 12, 24 months), Knee Society Score (preoperative and postoperative 6, 12, 24 months), Anterior and posterior stress view on X-ray (preoperative and postoperative 6, 12, 24 months).

Conditions

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Osteoarthritis, Patient-specific Instruments

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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patient-specific instruments group

procedure: PSI (patient-specific instruments) will be used as the cutting guide in total knee arthroplasty.

Group Type EXPERIMENTAL

patient-specific instruments

Intervention Type PROCEDURE

The Signature™ Vanguard

Intervention Type DEVICE

conventional instruments group

procedure: Conventional instruments will be used as the cutting guide in total knee arthroplasty.

Group Type ACTIVE_COMPARATOR

conventional instruments

Intervention Type PROCEDURE

Vanguard PS(posterior stabilized)

Intervention Type DEVICE

Interventions

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patient-specific instruments

Intervention Type PROCEDURE

The Signature™ Vanguard

Intervention Type DEVICE

conventional instruments

Intervention Type PROCEDURE

Vanguard PS(posterior stabilized)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* over 19 year old
* Patients for total knee arthroplasty of both knee
* over 5 degree in lateral bowing of femur
* having medicare insurance

Exclusion Criteria

* Rheumatoid arthritis
* Other inflammatory arthritis
* Neuropsychiatric patients
* Hepatic insufficiency
* Renal insufficiency
* over 40 of body mass index
* Chronic opioid use (taking opioids for longer than 3 months)
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Yong In

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong In, MD, PhD

Role: STUDY_CHAIR

the Catholic Univerisity of Korea Seoul St Mary's hospital

Central Contacts

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Yong In, MD, PhD

Role: CONTACT

Phone: 8290445228

Email: [email protected]

Youngjun Choi, MD

Role: CONTACT

Phone: 8258985857

Email: [email protected]

References

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ALShammari SA, Choi KY, Koh IJ, Kim MS, In Y. Total knee arthroplasty in femoral bowing: does patient specific instrumentation have something to add? A randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 2;22(1):321. doi: 10.1186/s12891-021-04198-5.

Reference Type DERIVED
PMID: 33794854 (View on PubMed)

Other Identifiers

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patient-specific instruments

Identifier Type: -

Identifier Source: org_study_id