Stability of Uncemented Medially Stabilized TKA

NCT04017533 | Completed DMC

• 1 other identifier: 424444-3
• Study Type: interventional
• Target: 31
• 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, patients' 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. The most common fixation mode is cemented TKR with good survival up to 15 years. However, newer series in younger patients also have shown lasting survival with uncemented implants (Nilsson et al 2006, Prudhon et al. 2017). Among various different designs, medially stabilized total knee, which are designed to reproduce natural knee kinematics with medial ball-in-socked design, is a promising implant (Australian registry report 2018). Dynamically the medial pivot knee performs more naturally (Bragnazoli et al, 2019) compared to other designs. Most data for this design is available only for the cemented version. Up to now there is no safety study performed that confirms the stability over time for this implant with uncemented fixation. In this study, we will therefore analyze the in vivo stability of an uncemented knee implant with medially stabilized design. Our study will contribute to the understanding of fixation and lead to safety to the patient.

Conditions

Knee Osteoarthritis

Keywords

Total Knee Arthroplasty (TKA); Total Knee Replacement (TKR); Radiostereometric Analysis; RSA; Medial Pivot; Medially stabilized; Medial pivoting; GMK Sphere; Global Medacta Knee Sphere

Outcome Measures

Primary Outcomes (1)

• MTPM

  Maximum Total Point Motion in mm

  2 years

Secondary Outcomes (5)

• Segmental RSA

  2 years

• DEXA of the proximal tibia

  2 years

• Conventional radiography

  2 years

• Forgotten Joint Score (FJS)

  2 years

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  2 years

Other Outcomes (1)

• Computer Tomography Motion Analysis

  2 years

Study Arms (1)

GMK Sphere

EXPERIMENTAL

Patients receive a cementless GMK Sphere Total Knee Replacement

Procedure: GMK Sphere TKR

Interventions

GMK Sphere TKR PROCEDURE

Se earlier

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 referred to Oslo University Hospital, Ullevål for knee replacement surgery will be included to this study for a total of 30 subjects.

You may not qualify if:

• and more years of age at the time of surgery
• Use of walking aids because of other muscoloskeletal and neuromuscular problems
• Preoperative diagnosis other than osteoarthritis and avascular necrosis (e.g. rheumatoid arthritis, tumors)
• Obesity with BMI\>35
• Lateral collateral ligament deficient knee
• Reduced bone quality in the proximal tibia before surgery
• Insufficient language to answer questionnaires in Norwegian

Sponsors & Collaborators

• Oslo University Hospital: lead
• Medacta International SA: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0470, Norway

Location

Related Publications (37)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephan M Röhrl, MD, PhD

  CIRRO Oslo university hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single group diagnostic safety study of a medial pivot cementless knee implant. Diagnostic methods used are RSA and CT-RSA, to study the safety of a medial pivot cementless knee implant.

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 12, 2019
• Study Start: September 4, 2021
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)