Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty

NCT02993016 | Unknown

• 1 other identifier: patient-specific instruments
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Osteoarthritis, Patient-specific Instruments

Outcome Measures

Primary Outcomes (1)

• Changes in Range of Motion (ROM)

  Changes from Baseline Range of Motion at postoperative 1 year

Secondary Outcomes (3)

• Changes in WOMAC (Western Ontario and McMaster University Arthritis Index)

  Changes from Baseline score to score of postoperative 1 year

• Changes in Knee Society Score

  Changes from Baseline score to score of postoperative 1 year

• Changes in Anterior and posterior stress view on X-ray

  Changes from Baseline Anterior and posterior stress view on X-ray at postoperative 1 year

Study Arms (2)

patient-specific instruments group

EXPERIMENTAL

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

Procedure: patient-specific instruments; Device: The Signature™ Vanguard

conventional instruments group

ACTIVE COMPARATOR

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

Procedure: conventional instruments; Device: Vanguard PS(posterior stabilized)

Interventions

patient-specific instruments PROCEDURE

patient-specific instruments group

The Signature™ Vanguard DEVICE

patient-specific instruments group

conventional instruments PROCEDURE

conventional instruments group

Vanguard PS(posterior stabilized) DEVICE

conventional instruments group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Catholic University of Korea: lead

Related Publications (1)

• 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.

  PMID: 33794854 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Yong In, MD, PhD

  the Catholic Univerisity of Korea Seoul St Mary's hospital

  STUDY CHAIR

Central Study Contacts

Yong In, MD, PhD

CONTACT

8290445228; iy1000@catholic.ac.kr

Youngjun Choi, MD

CONTACT

8258985857; wogur79@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: December 14, 2016

Record last verified: 2016-12