Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation

NCT ID: NCT01108237

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-01
• Study Completion Date: 2011-03-01

Brief Summary

This investigation is intended to provide clinical information about alignment using TruMatch™ and to compare the results to a conventional total knee replacement. TruMatch™ will be compared to a historical control study, which compares alignment results of computer aided surgery (CAS) and conventional surgical techniques.

The purpose of this investigation is to determine whether TruMatch™ alignment is non-inferior to alignment achieved with conventional instrumentation. This investigation will compare long leg alignment in total knee replacement achieved by the two types of procedures. Radiographic analysis will be performed by the same independent radiographic reviewer as the historical control study.

Detailed Description

The study is designed as a prospective, multi-center, non-randomized, clinical investigation to determine whether TruMatch™ alignment is non-inferior to alignment achieved in a recently completed study (historical control) with conventional instrumentation.

Each enrolled Subject will undergo a total knee replacement using the TruMatch™ surgical technique. This investigation will require the Subject to be followed once postoperatively to collect radiographs. Follow-up will occur typically 2 to 12 weeks after surgery and when the Subject can achieve full leg extension (+/-5 degrees) and can tolerate weight-bearing.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TruMatch™ Personalized Solutions

Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions

Group Type: OTHER

TruMatch™ Personalized Solutions

Intervention Type: OTHER

TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.

Historical Control

Total Knee Arthroplasty (PFC Sigma System) implanted using conventional and CAS surgical techniques without TruMatch™ instrumentation.

Group Type: OTHER

Total Knee Arthroplasty with Conventional Instrumentation.

Intervention Type: DEVICE

Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.

Interventions

TruMatch™ Personalized Solutions

TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.

Intervention Type: OTHER

Total Knee Arthroplasty with Conventional Instrumentation.

Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects meeting all of the following specific criteria will be considered for participation in the study:
• Subject is male or female and between the ages of 18 and 80 years old, inclusive.
• Subject requires a primary total knee replacement and is considered by the Investigator to be suitable for the specific knee prosthesis identified in the protocol.
• Subject has given voluntary, written informed consent to participate in this clinical investigation and has authorized the transfer of his/her information to DePuy.
• Subject has given consent to the transfer of his/her information to DePuy.
• Subject, who, in the opinion of the Clinical Investigator at the time of preoperative planning, are suitable for implantation using TruMatch™ instrumentation and whose surgical plan (patient proposal) is approved. For example, no femoral nails/bone plates that extend into the knee, i.e. within 8cm of joint line; no metal device that could cause CT scatter about the knee and no deformities greater than 15 degrees of fixed varus, valgus, or flexion

Exclusion Criteria

• Subjects will be excluded from participation in the trial if they meet any of the following criteria:
• The Subject has, in the opinion of the Investigator, an existing condition that would compromise their participation and follow-up in this study.
• The Subject is a woman who is pregnant or lactating.
• The Subject is a known drug or alcohol abuser or has a psychological disorder that could affect follow-up care or treatment outcomes.
• The Subject has participated in a clinical investigation with an investigational product in the last 3 months.
• The Subject is currently involved in any personal injury litigation, medical-legal or worker's compensations claims.
• The Subject has previously had a prosthetic knee replacement device (any type including unicompartmental, total knee arthroplasty, patellofemoral arthroplasty) of the affected knee or a previous patellectomy.
• The Subject presents ankylosis of the hip joint on the side to be treated or previous ipsilateral UTO/HTO.
• The Subject requires simultaneous bilateral total knee replacements.
• The Subject had a contralateral TKA and that knee was previously entered in the study.
• Subject in whom the surgeon intends to implant a knee prosthesis that is not the cruciate retaining or posterior substituting PFC Sigma total knee arthroplasty.
• Subjects who have inflammatory arthritis

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saleem Himden, BA

Role: STUDY_DIRECTOR

DePuy Orthopaedics

Locations

Towson Orthopaedic Associates

Baltimore, Maryland, United States

Summit Orthopaedics, LTD

Saint Paul, Minnesota, United States

OrthoCarolina

Charlotte, North Carolina, United States

Valley Orthopaedic Associates

Renton, Washington, United States

Countries

United States

Other Identifiers

08003

Identifier Type: -

Identifier Source: org_study_id