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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01108237
First received: April 1, 2010
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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 Intervention
Osteoarthritis, Knee
Other: TruMatch™ Personalized Solutions
Device: Total Knee Arthroplasty with Conventional Instrumentation.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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:
  • Compare Intraoperative Time Data (Skin-to-skin, Tourniquet, Tourniquet to Bone) [ Time Frame: During the Procedure ] [ Designated as safety issue: No ]
  • Compare AP Tibial/Femoral Component Alignment [ Time Frame: Pre-op, 3 months ] [ Designated as safety issue: No ]
  • Sagittal Component Alignment [ Time Frame: Pre-Op, 3 months ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: October 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108237

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

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT01108237     History of Changes
Other Study ID Numbers: 08003
Study First Received: April 1, 2010
Results First Received: March 27, 2012
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014