Does the Use of Patient Specific Instrumentation Improve Outcomes in Knee Arthroplasty Surgery for Osteoarthritis When Compared to Standard Posterior Referenced Instrumentation?

NCT06720012 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: 53210-13
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized study is to see if using patient-specific instruments (PSI) during total knee replacement surgery improves outcomes compared to standard instruments. The study focuses on adults with knee osteoarthritis who need knee replacement surgery. Specifically, it aims to answer the following questions: Does using PSI improve knee function and stability as experienced by the patient? Does PSI lead to more normal knee motion during bending and straightening? Does PSI result in at least as good tibial (shin bone) component fixation as standard instruments? Is PSI more cost-effective than standard instruments? Researchers will compare PSI with standard instruments in 70 patients. Half will receive knee replacement surgery using PSI, and the other half with standard instruments. Patients will be randomly assigned to each group. Participants will: Undergo knee replacement surgery with either PSI or standard instruments. Have a series of follow-ups, including assessments of knee function, satisfaction, and alignment of the knee implant, conducted before surgery and at 3 months, 1 year, 2 years, and 5 years after surgery. The study will include patients aged 40-75 with primary osteoarthritis, a body mass index (BMI) below 35, and no other major medical conditions that could impact surgery. Patients will also need to be willing to undergo necessary imaging, such as magnetic resonance imageing (MRI) scans and standing X-rays. Outcomes will be measured using various assessment tools, including the Oxford Knee Score, Knee Society Score, and a patient satisfaction survey. Researchers will also record surgery details, such as operating time, blood loss, and knee implant size. Imaging methods, including MRI, computed tomgraphy (CT) scans, and specialized X-rays, will be used to evaluate knee alignment and stability over time. The results of this study are expected to provide insights into whether patient-specific instruments offer clinical or economic advantages over traditional tools in knee replacement surgery.

Conditions

Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery; Osteoarthritis (OA) of the Knee

Keywords

Patient Specific Instrumentation; Total Knee Arthroplasty; Zimmer PSI; NexGen; Materialise

Outcome Measures

Primary Outcomes (1)

• Oxford Knee Score (OKS)

  A instrument validated for use in Sweden for measuring patient reported functional outcomes following knee arthroplasty. The OKS is widely used due to its reliability and sensitivity to clinically meaningful improvements in knee function after TKA. The score ranges from 12-48 points with a minimal important change of 8 and a ceiling reported to be around 44-48 points.

  Prior to and 2 years post surgery

Secondary Outcomes (7)

• Knee Society Knee Score (KSKS)

  Prior to and up to 5 years post surgery

• Oxford Knee Score (OKS)

  Prior to and up to 5 years post surgery

• EuroQol EQ-5D-3L

  Prior to and up to 5 years post surgery

• Pain and Patient Satisfaction Visual Analogue Scales (VAS)

  (Prior to) and up to 5 years post surgery

• Radiographic evaluation

  Postoperatively, up to three months postop.

Other Outcomes (1)

• Number of patients undergoing revision surgery

  Up to 5 years post surgery

Study Arms (2)

Patient Specific Instrumentation (PSI)

EXPERIMENTAL

PSI cutting guides modeled from a MRI preoperatively and based on the patients unique anatomy.

Device: Patient specific instrumentation (PSI); Procedure: Cemented Total Knee Arthroplasty

Conventional Instrumentation

ACTIVE COMPARATOR

Conventional jig-based intra- and extramedullary instrumentation for the NexGen Knee System.

Device: Conventional instruments; Procedure: Cemented Total Knee Arthroplasty

Interventions

Patient specific instrumentation (PSI) DEVICE

Cutting guides that are manufactured using advanced imaging and modelling techniques to create instruments that align more closely with the unique anatomy of each patient. Custom guides were created based on a preoperative MRI protocol (Zimmer Patient Specific Instrumentation for NexGen® Complete Knee Solution, Zimmer Biomet, Warsaw, Indiana, United States in collaboration with Materialise NV, Leuven, Belgium) to optimize the placement of the components without the need for intramedullary alignment.

Also known as: Patient specific cutting guides, Patient-specific guides, Custom instrumentation, Extramedullary femoral cutting system, Patient-matched instruments

Patient Specific Instrumentation (PSI)

Conventional instruments DEVICE

Instruments specific to the implant that are used to guide bone cutting in reference to the intramedullary canal or using an extramedullary jig.

Also known as: Traditional jig-based instruments, Traditional cutting guides, Jig-based instrumentation, Intra- and extramedullary cutting guides

Conventional Instrumentation

Cemented Total Knee Arthroplasty PROCEDURE

A cemented TKA (NexGen® Complete Knee Solution, Zimmer Biomet, Warsaw, Indiana, United States) is used in all cases with a cruciate retaining (CR) or posterior stabilized (LPS) prosthesis as determined by the surgeon.

Conventional Instrumentation; Patient Specific Instrumentation (PSI)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medial or lateral primary osteoarthritis (OA) Ahlbäck Grade 2-4
• Varus or valgus deformity ≤10 degrees, extension defect ≤10 degrees
• Age 40-75 years
• BMI \<35
• American Society of Anesthesiologists (ASA) score 1-3.
• Coming from independent living in own home
• Able and willing to undergo MRI scan (for custom patients), full-leg standing radiographs and follow up with RSA
• Written informed consent.

You may not qualify if:

• Cortisone treatment during the last 6 months before operation
• Neurological diseases with symptoms, stroke with sequel
• Endocrine diseases with symptoms
• OA secondary to trauma, infection, inflammatory disease or congenital and acquired deformities
• BMI \>=35
• OA of the hip with symptoms
• Ongoing infection
• Any metal within 150 mm from the joint line on the side to become operated
• Unable or unwilling to participate in the follow-up.

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• Zimmer Biomet: collaborator
• Ingabritt och Arne Lundbergs Forskningsstiftelse: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Mölndal, Västra Götalandsregionen, 43180, Sweden

Location

Related Publications (2)

• Nunley RM, Ellison BS, Zhu J, Ruh EL, Howell SM, Barrack RL. Do patient-specific guides improve coronal alignment in total knee arthroplasty? Clin Orthop Relat Res. 2012 Mar;470(3):895-902. doi: 10.1007/s11999-011-2222-2. Epub 2011 Dec 20.

  PMID: 22183477 BACKGROUND

• Ast MP, Nam D, Haas SB. Patient-specific instrumentation for total knee arthroplasty: a review. Orthop Clin North Am. 2012 Nov;43(5):e17-22. doi: 10.1016/j.ocl.2012.07.004. Epub 2012 Sep 10.

  PMID: 23102417 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 6, 2024
• Study Start: March 3, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)