Stability of Uncemented Medially Stabilized TKA
Key facts
- Who runs it
- Oslo University Hospital
- Where
- Norway1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 31 people enrolled
- Started
- 4 Sept 2021
- Ended
- 10 Oct 2024
- Type of study
- Interventional
- Treatments tested
- GMK Sphere TKR
- Record updated
- 25 November 2025
Who can take part
- Age
- 50 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Patients referred to Oslo University Hospital, Ullevål for knee replacement surgery will be included to this study for a total of 30 subjects
Who cannot take part
- Reduced bone quality in the proximal tibia before surgery
- 75 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
- Insufficient language to answer questionnaires in Norwegian
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- GMK SphereTreatment being tested
Patients receive a cementless GMK Sphere Total Knee Replacement
Treatment: GMK Sphere TKR
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- In Vivo Stability of an Uncemented Total Knee Arthroplasty With Medially Stabilized Design
- Record updated
- 25 November 2025