Clinical trial NCT01108237: Alignment Comparison Between TruMatch™ Personalized Solutions and Conventional Total Knee Replacement Instrumentation
Official title: Comparison of In Vivo Alignment With TruMatch™ Personalized Solutions Compared to Conventional Instrumentation in Total Knee Replacement (TKR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: 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
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2010-04-21
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mechanical Axis Alignment(Absolute Value Measured in Degrees)Using 51 Inch Long Leg Films
timeFrame: 12 weeks postoperatively (when subject has reached full knee extension)
Secondary outcomes:
measure: Compare Intraoperative Time Data During Procedure for Skin-to-skin Time in Minutes
timeFrame: During the Procedure
measure: Tourniquet Time Measured in Minutes During the Procedure for TruMatch and Conventional Instruments
timeFrame: During the Procedure
measure: Tourniquet to 1st Bone Cut Measured in Minutes During the Procedure for TruMatch and Conventional Instruments
timeFrame: During the Procedure
measure: Coronal Alignment Femoral and Tibial
timeFrame: 3-months
measure: Sagittal Component Alignment
timeFrame: Collected at Pre-Op, 3 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Towson Orthopaedic Associates
state: Maryland
city: Saint Paul
country: United States
facility: Summit Orthopaedics, LTD
state: Minnesota
city: Charlotte
country: United States
facility: OrthoCarolina
state: North Carolina
city: Renton
country: United States
facility: Valley Orthopaedic Associates
state: Washington
Study officials:
affiliation: DePuy Orthopaedics
name: Saleem Himden, BA
role: STUDY_DIRECTOR
References: