Kinematic Analysis of a PS, FB Primary Total Knee Arthroplasty (ATTUNE Knee System) Using Dynamic RSA

NCT02323386 | Completed

• 1 other identifier: 46/13
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Across the European Union there are 535,000 Total Knee Arthroplasty (TKA)per year. Statistics indicate that for patients over 60 year old approximately one out of 20 will require corrective reoperations within 10 years after surgery. However, for patients younger than 60 years, approximately one out of 10 will require revision total knee arthroplasty within 10 years of surgery. As the number of younger patients is increasing, there has been a shift in focus in total Knee Replacement (TKR) outcome, with post-operative function and implant longevity being the important issues for quality of patient care. Furthermore, it has been reported that up to 25% of patients are not satisfied with the functional results of their TKA. In vivo the gold standard for obtaining reliable 3D measurements is RSA. However these are often static, because of even most advanced x-ray film exchanger limit the number of pictures taken to less than 10 per second. Our dynamic RSA technique allows producing real time x-ray video of TKA in weight-bearing (WB) conditions with active muscle contraction. The purpose of this study is to investigate the effect of a new implant design on the post-operative active knee kinematics, focusing on mid-flexion instability of the joint. A prospective randomized study will be performed on a new implant: the DePuy ATTUNETM fixed-bearing (FB) posterior-stabilized (PS) knee prosthesis.

Conditions

Osteoarthritis

Keywords

Dynamic RSA; Knee; Total Knee Arthroplasty; Kinematic Analysis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the femoral rotations and translations during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking.

  The joint kinematic was acquired using the dynamic RSA technique. The rotations (angular degree) and translations (millimeter) were evaluated using the Euler decomposition and the Low-point algorithm.

  9 months

Secondary Outcomes (2)

• Correlation of clinical reported results (KSS, Oxford, SF36, WOMAC) and patients' subjective satisfaction using a visual analogue scale (VAS) with kinematics differences and ground reaction forces.

  9 months

• Quantification the ground reaction forces during weight-bearing motor tasks with active muscle contraction: step descent, full flexion movement, level walking.

  9 months

Study Arms (1)

ATTUNE knee system

EXPERIMENTAL

The patients will undergo primary Total Knee Arthroplasty (ATTUNE knee system)

Device: Primary Total Knee Arthroplasty (ATTUNE Knee System)

Interventions

Primary Total Knee Arthroplasty (ATTUNE Knee System) DEVICE

The patient will undergo primary Total Knee ArthroplastY use ATTUNE Knee System. During surgery a navigation system will be used to record preoperative joint kinematics under different tests. During the test the 6 degrees of freedom (DOF) of the joint will be computed and shown to the surgeon; these are the femoral rotation and translation pattern against flexion ranges. Navigation system will be also used to monitor the implant positioning and possible surgical bias. Dynamic RSA will be used to analyze the in vivo kinematics of the prosthesis at 6 months follow-up. The above mentioned motion tests will be performed 3 times. The first 2 will be executed to gain comfort with the experimental set-up with no X-ray exposure. During the last data is collected.

ATTUNE knee system

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe radiographic osteoarthritis (Kellgren-Lawrence grade \>3)
• Patients scheduled for a primary TKA
• Willing to take part in study and providing HIPAA authorization

You may not qualify if:

• Previous corrective osteotomy on the affected lower limb
• Post-traumatic arthritis
• Severe preoperative valgus deformity (Hip Knee Ankle angle\>10°)
• BMI\>40 kg/m2
• Rheumatoid arthritis
• Chronic inflammatory joint diseases
• Patients with a pre-pathological abnormal gait (amputated, neuromuscular disorders, poliomyelitis, developmental dysplasia of the hip)
• Severe ankle osteoarthritis (Kellgren-Lawrence\>3)
• Severe hip osteoarthritis (Kellgren-Lawrence\>3)
• Previous total hip or ankle replacement
• Unwilling to take part in study and providing HIPAA authorization

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• DePuy International: collaborator

Study Sites (1)

Rizzoli Orthopaedic Institute

Bologna, 40136, Italy

Location

Related Publications (1)

• Di Paolo S, Agostinone P, Grassi A, Lucidi GA, Pinelli E, Bontempi M, Marchiori G, Bragonzoni L, Zaffagnini S. Dynamic Radiostereometry Evaluation of 2 Different Anterior Cruciate Ligament Reconstruction Techniques During a Single-Leg Squat. Orthop J Sports Med. 2021 Jul 15;9(7):23259671211011940. doi: 10.1177/23259671211011940. eCollection 2021 Jul.

  PMID: 34350300 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Maurilio Marcacci, MD

  Rizzoli Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

• Laura Bragonzoni, SportScience

  Alma Mater Studiorum - University of Bologna

  STUDY DIRECTOR

• Danilo Danilo, MD

  Rizzoli Orthopaedic Institute

  STUDY CHAIR

• Bontempi Marco, Physicist

  Rizzoli Orthopaedic Institute

  STUDY DIRECTOR

• Maria Pia Neri, MD

  Rizzoli Orthopaedic Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 23, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2016
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)