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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Other: TruMatch™ Personalized Solutions; Device: Total Knee Arthroplasty with Conventional Instrumentation.	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	78 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Comparison of In Vivo Alignment With TruMatch™ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKR)
Study Start Date :	October 2009
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	March 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
TruMatch™ Personalized Solutions; Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions	Other: 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.
Historical Control; Total Knee Arthroplasty (PFC Sigma System) implanted using conventional and CAS surgical techniques without TruMatch™ instrumentation.	Device: Total Knee Arthroplasty with Conventional Instrumentation.; Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.

Outcome Measures

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Primary Outcome Measures :

1. Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films [ Time Frame: 12 weeks postoperatively (when subject has reached full knee extension) ]
   Limb alignment in TKR is important for accurate implant positioning. It is measured by looking at the mechanical axis of the limb. This axis is an imaginary line that starts at center of the femoral head and ends in the center of the talus. In a knee with normal alignment, this line (axis) passes near the joint center. Before surgery, the planned joint angle is recorded. This study measured the difference between the mechanical axis angle reached after surgery and the planned angle. Subjects with a mechanical alignment within 3 degrees of the planned angle were considered a success.

Secondary Outcome Measures :

1. Compare Intraoperative Time Data (Skin-to-skin, Tourniquet, Tourniquet to Bone) [ Time Frame: During the Procedure ]
2. Compare AP Tibial/Femoral Component Alignment [ Time Frame: Pre-op, 3 months ]
3. Sagittal Component Alignment [ Time Frame: Pre-Op, 3 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Maryland
Towson Orthopaedic Associates
Baltimore, Maryland, United States, 21204
United States, Minnesota
Summit Orthopaedics, LTD
St. Paul, Minnesota, United States, 55102
United States, North Carolina
OrthoCarolina
Charlotte, North Carolina, United States, 28207
United States, Washington
Valley Orthopaedic Associates
Renton, Washington, United States, 98055-5791

Sponsors and Collaborators

DePuy Orthopaedics

Investigators

Study Director:	Saleem Himden, BA	DePuy Orthopaedics

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	DePuy Orthopaedics
ClinicalTrials.gov Identifier:	NCT01108237 History of Changes
Other Study ID Numbers:	08003
First Posted:	April 21, 2010
Results First Posted:	May 21, 2012
Last Update Posted:	January 24, 2014
Last Verified:	December 2013

Keywords provided by DePuy Orthopaedics:

Arthroplasties, Knee Replacement; Arthroplasties, Replacement, Knee; Arthroplasty, Knee Replacement; Knee Replacement Arthroplasties; Knee Replacement Arthroplasty	Knee Replacement, Total; Replacement Arthroplasties, Knee; Replacement Arthroplasty, Knee; Replacement, Total Knee; Total Knee Replacement

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases	Musculoskeletal Diseases; Rheumatic Diseases; Pharmaceutical Solutions