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

Osteoarthritis, Knee Clinical Trial

Official title:

Comparison of In Vivo Alignment With TruMatch™ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108237
• Other study ID #: 08003
• Status: Completed
• Phase: N/A
• Start date: October 1, 2009
• Est. completion date: March 1, 2011

Study information

• Verified date: October 2023
• Source: DePuy Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 1, 2011
• Est. primary completion date: March 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

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.

Device:
• Total Knee Arthroplasty with Conventional Instrumentation.
Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.

Locations

Country	Name	City	State
United States	Towson Orthopaedic Associates	Baltimore	Maryland
United States	OrthoCarolina	Charlotte	North Carolina
United States	Valley Orthopaedic Associates	Renton	Washington
United States	Summit Orthopaedics, LTD	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films	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.	12 weeks postoperatively (when subject has reached full knee extension)
Secondary	Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes	Intraoperative (skin to skin) time was measured to the nearest minute. TruMatch personalized Solutions and Conventional instrumentation outcomes are provided	During the Procedure
Secondary	Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments	Intraoperative Tourniquet time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes are provided	During the Procedure
Secondary	Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments	Intraoperative Tourniquet to 1st Bone Cut time was measured to the nearest minute. TruMatch and Conventional instrumentation outcomes provided	During the Procedure
Secondary	Coronal Alignment Femoral and Tibial	Femoral Component to mechanical axis (degrees) and Tibial component to mechanical axis (degrees)	3-months
Secondary	Sagittal Component Alignment	Sagittal Component Alignment analyzed and reported at 3- months	Collected at Pre-Op, 3 months