Kinematics of Contemporary Knee Arthroplasty

NCT02965690 | Active Not Recruiting DMC

• 1 other identifier: 424444-2
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both total knee replacement (TKR) and total hip replacements (THR) have excellent implant survivorship. However, patient satisfaction is lower in TKR than THR. A possible cause of the discrepancy is the unnatural knee kinematics after TKR. Various implant designs have been developed to solve the problem. However, most of the designs are based on experimental data and not on in vivo kinematics. In this study, we will analyze the in vivo kinematics of the Global Medacta Knee Sphere (GMK Sphere) implant and compare it with a well documented design and implant (NexGen Cruciate Retaining (CR), Zimmer Biomet). We assume our study will contribute to the development of more satisfying knee implants.

Conditions

Knee Osteoarthritis

Keywords

Total Knee Arthroplasty (TKA); Total knee replacement (TKR); Knee kinematics; Dynamic RSA; Fluoroscopy; Fluoroscopic Roentgen Stereophotogrammetric Analysis (FRSA); Medial pivot; Medially stabilized

Outcome Measures

Primary Outcomes (1)

• Knee Kinematics measured though all Degrees of freedom (DOF)

  Roentgen Fluoroscopic Stereophotogrammetric Analysis (RFSA). We measure all DOFs (i.e. X-Y-Z rotations and translations in degrees and millimeters respectively)

  1 year

Secondary Outcomes (7)

• Knee Society Score (KSS)

  1 year

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  1 year

• Forgotten Joint Score 12 (FJS-12)

  1 year

• Range of motion (ROM)

  1 year

• Hip-knee-ankle angle (HKA-angle)

  1 year

Study Arms (2)

Zimmer Biomet NexGen CR

ACTIVE COMPARATOR

Patients receive a Zimmer Biomet NexGen Total Knee Replacement

Procedure: Zimmer Biomet NexGen CR

Medacta International GMK Sphere

ACTIVE COMPARATOR

Patients receive a Medacta International, GMK Sphere Total Knee Replacement

Procedure: Medacta International GMK Sphere

Interventions

Zimmer Biomet NexGen CR PROCEDURE

Total Knee Replacement

Zimmer Biomet NexGen CR

Medacta International GMK Sphere PROCEDURE

Total Knee Replacement

Medacta International GMK Sphere

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients with knee osteoarthritis

You may not qualify if:

• Preoperative severe deformity (Femoro-tibial angle \< 175°or \> 190° measured on a full-length leg image at weight bearing)
• Preoperative flexion contracture more than 15°
• Preoperative limited range of motion under anesthetics (less than 110°)
• Less than 50 or more than 75 years of age at the time of surgery
• Use of walking aids because of other musculoskeletal and neuromuscular problems
• Preoperative diagnosis other than osteoarthritis and avascular necrosis (e.g. rheumatoid arthritis, tumors)
• Revision arthroplasty
• Obesity with BMI\>35
• Impaired collateral ligaments
• Postoperative KOOS score less than 80
• Malposition of femoral and tibial implants (Internally rotated or more han 10° externally rotated implants will be excluded. The rotation of femoral implant is measured on postoperative CT images in reference to surgical epicondylar line. The rotation of tibial implant is determined according to Berger's measurement)
• Limb surgery within 3 months before the analysis
• Postoperative revision surgery due to deep wound infection

Sponsors & Collaborators

• Oslo University Hospital: lead
• Helse More and Romsdal Trust: collaborator

Study Sites (1)

Oslo University Hospital, Ullevål

Oslo, 0470, Norway

Location

Related Publications (27)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Frank-David Oehrn, MD

  CIRRO and Kristiansund Hospital, Helse More and Romsdal Trust

  PRINCIPAL INVESTIGATOR

• Stephan Maximillian Røhrl, PhD

  CIRRO and Oslo University Hospital, Ullevål

  STUDY DIRECTOR

• Lars Harald William Engseth, MD

  CIRRO and Oslo University Hospital, Ullevål

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Non-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, orthopaedic consultant

Model Details: Prospective, parallel-group, non-blind, randomized clinical study

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 17, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)