Stability of Contemporary Knee Arthroplasty

NCT02861794 | Completed DMC

• 1 other identifier: 424444-1
• Study Type: interventional
• Target: 44
• 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 implants designs have been developed to solve the problem. However, most of their designs are based on experimental data and little has been studied about their actual performance in vivo. In this study, the investigators will analyze the in vivo stability of the Global Medacta Knee Sphere (GMK Sphere) implant. Migration of the implants will be monitored with a high precision measuring method called Radiostereometric Analysis (RSA). The investigators assume the investigators study will contribute the development of more satisfying knee implants.

Conditions

Knee Osteoarthritis

Keywords

Total Knee Arthroplasty (TKA); Total Knee Replacement (TKR); Kinematics; RSA; Knee arthroplasty; Implant stability; Migration; Wear; Medial pivot

Outcome Measures

Primary Outcomes (1)

• Stability of the GMK Sphere prosthesis measured by Radiostereometric Analysis (RSA)

  Stability of the implant is measured in mm after 5 years (Maximum Total Point Motion in mm, MTPM)

  5 years

Secondary Outcomes (7)

• Knee Society Score (KSS)

  5 years

• Forgotten Joint Score 12 (FJS-12)

  5 years

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  5 years

• Range of motion (ROM)

  5 years

• Hip-knee-ankle angle (HKA-angle)

  5 years

Study Arms (1)

GMK Sphere

OTHER

Patients receive a GMK Sphere Total Knee Replacement.

Procedure: Medacta International, GMK Sphere medially stabilized knee

Interventions

Medacta International, GMK Sphere medially stabilized knee PROCEDURE

Total Knee Replacement

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
• Malposition of femoral and tibial implants (Internally rotated or more than 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)
• Postoperative revision surgery due to deep wound infection

Sponsors & Collaborators

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

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0470, Norway

Location

Related Publications (28)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephan Maximillian Røhrl, MD, PhD

  Center for Implant and Radiostereometric Research Oslo (CIRRO)

  STUDY DIRECTOR

• Frank-David Oehrn, MD

  Kristiansund Hospital, Helse More and Romsdal Trust

  PRINCIPAL INVESTIGATOR

• Lars Harald William Engseth, MD, PhD

  Center for Implant and Radiostereometric Research Oslo (CIRRO)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Non-blind
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. professor

Model Details: Prospective interventional single group cohort study of a cemented medial pivot knee implant, using the diagnostic method of RSA.

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: August 10, 2016
• Study Start: May 1, 2016
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)