Clinical Outcomes & Cost-effectiveness Analysis of ShapeMatch Technology

Status Terminated

Clinical Trial Summary

The currently held belief is that total knee replacement (TKR) requires the restoration of the overall limb alignment to coincide with the mechanical limb axis. To align the knee implants with this mechanical axis, rods are used to orient cutting guides with the mechanical axis as defined by the center of the femoral head and talus. Standard surgical technique typically involves femoral and tibial rods with cutting blocks to facilitate the intraoperative alignment of the initial femoral and tibia bone cuts. This approach is the method used for the traditional TriathlonÒ instrumentation. The Patient Specific Cutting Guides are designed to offer an alternative for alignment rods. ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment. The surgeon can then assess implant placement and adjust as necessary during pre-operative planning. Thus, Patient Specific Cutting Guides give the surgeon better control over the placement of the implants. This study will be a prospective, randomized evaluation of ShapeMatch Technology for primary TKR in a consecutive series of patients who meet the eligibility criteria. The clinical study will be accompanied by a formal cost-effectiveness analysis of one-year outcomes. One half of the cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides designed to reproduce the natural kinematic alignment of the knee. The other half of the cases will receive the Triathlon® CR device in a procedure using traditional instrumentation, without navigation, designed to produce a neutral mechanical alignment. Subjects will be evaluated using validated measures within 3 months prior to surgery and at 6 weeks, 3 months, and 1 and 2 years postoperatively. Primary Hypothesis: The investigators expect that ShapeMatch Technology will be as cost-effective as usual care. Secondary Hypotheses: The investigators expect that ShapeMatch Technology will result in improved clinical outcomes relative to usual care at three months postoperatively. The investigators expect that ShapeMatch Technology will result in similar clinical outcomes relative to usual care at two-years postoperatively.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Total Knee Arthroplasty

Clinical Trial Details

NCT number	NCT01483066
Study type	Interventional
Source	University of Alberta
Contact
Status	Terminated
Phase	Phase 4
Start date	June 2012
Completion date	June 26, 2015

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See also
Status	Clinical Trial	Phase
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Recruiting	`NCT06061367` - Muscles Strength and Gait Parameteres After TKA
Recruiting	`NCT05391828` - Persona MC vs PS RCT With ROSA	N/A
Active, not recruiting	`NCT04850300` - Efficiency Assessment of the Methodology for the Follow-up of Patients With Knee Prostheses	Phase 3
Completed	`NCT05635916` - Trial of Liposomal Bupivacaine for TKA	Phase 4
Enrolling by invitation	`NCT05130216` - Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain After Total Knee Arthroplasty
Withdrawn	`NCT02495805` - Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty	N/A
Completed	`NCT03206554` - Local Infiltration Analgesia in Total Knee Arthroplasty	Phase 2
Withdrawn	`NCT01511211` - Duration of Leg Nerve Blocks With Dexamethasone Added to Local Anesthetic	Phase 4
Completed	`NCT01616836` - Optimizing Pain and Rehabilitation After Knee Arthroplasty	Phase 3
Not yet recruiting	`NCT00958945` - Retrospective Chart Analysis in the Effective Use of FloSeal in Post-Operative Joint Replacements	N/A
Completed	`NCT00985920` - Topical Tranexamic Acid for Total Knee Arthroplasty	Phase 4
Completed	`NCT00761956` - A Study to Compare the NexGen CR and CR-Flex Knee Implants	N/A
Completed	`NCT03289247` - Tissue Adhaesive in Wound Closure Following Primary Total Knee Arthroplasty	N/A
Terminated	`NCT03316118` - US Guided GNB vs Saline Injection for TKA	Phase 4
Recruiting	`NCT05962970` - Continuous Adductor Canal Block in Fast Track Total Knee Arthroplasty	N/A
Completed	`NCT03317834` - Navio With Total Knee Arthroplasty
Enrolling by invitation	`NCT06188091` - Joint Movement to Increase Range of Motion in Knee Joint After Primary Total Knee Arthroplasty	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Outcomes and Cost-effectiveness Analysis of ShapeMatch Technology

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms