An interventional study of H-MAX stem & Delta-TT cup + polyethylene and H-MAX stem & Delta-TT cup + ceramic in Osteoarthrosis, sponsored by JointResearch. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-13.
Sponsored by JointResearch · Not applicable, Interventional, and Treatment
The goal of this study is to study the stability of the Delta-TT cup with polyethylene insert and the Delta-TT cup with ceramic insert both combined with the H-MAX femoral stem by means of RSA to assess whether the differences in stiffness of the cup will have an influence on incorporation and mechanical stability.
It is hypothesized that there will be more micromotion on the short-term (\<2 years) in the patients with the ceramic insert because of the higher stiffness, however, all components will be considered stable on the short and long-term.
Rationale: Roentgen Stereophotogrammetric Analysis (RSA) is a very accurate measurement technique used to obtain micromotion of the implants relative to inserted tantalum markers in the surrounding bone. Using RSA, long-term predictions of prosthetic loosening can be made based on a two years follow-up. Therefore, it is recommended to analyse all (new) prosthetic components by means of RSA.
Objective: The goal of this study is to study in a randomised trial the stability of the Delta-TT cup with polyethylene insert and the Delta-TT cup with ceramic insert both combined with the H-MAX femoral stem by means of RSA to assess whether the differences in stiffness of the cup will have an influence on incorporation and mechanical stability. It is hypothesized that there will be more micromotion on the short-term (\<2 years) in the patients with the ceramic insert because of the higher stiffness, however, all components will be considered stable on the short and long-term. Secondary goal is to compare the stability of the C2 femoral stem, to the H-MAX femoral stem as well as to compare it to relevant migration results of similar stems from the literature. These RSA results will contribute to knowledge about the early stability and long-term prosthetic loosening of these cementless stems.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 70 is close to the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →JointResearch is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
H-MAX femoral stem and the Delta-TT cup with polyethylene insert
Device: H-MAX stem & Delta-TT cup + polyethylene
H-MAX femoral stem and the Delta-TT cup with ceramic insert
Device: H-MAX stem & Delta-TT cup + ceramic
C2 femoral stem and the Delta-TT cup with ceramic insert
Device: C2 stem & Delta-TT cup + ceramic
H-MAX femoral stem \& Delta-TT cup with a polyethylene insert
H-MAX femoral stem \& Delta Delta-TT cup with a Ceramic insert
C2 femoral stem Delta Delta-TT cup with a Ceramic insert
Change from Baseline in stability
Stability will be assessed with Roentgen Stereophotogrammetric Analysis (RSA). RSA will be used to determine the micromotion of the femur and cup components with respect to the bone.The RSA data of the components will be described in terms of translational and rotational movements.
Time frame: 2 years
Change from Baseline in Quality of Life
Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D)
Time frame: 2 years
Change from Baseline in Quality of Life
Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D)
Time frame: 5 years
Change from Baseline in Physical Function
Physical Function will be assessed with the Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS)
Time frame: 2 years
Change from Baseline in Physical Function
Physical Function will be assessed with the Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS)
Time frame: 5 years
Change from Baseline in Physical Function and Pain
Physical Function will be assessed with the Oxford Hip Score (OHS)
Time frame: 2 years
Change from Baseline in Physical Function and Pain
Physical Function will be assessed with the Oxford Hip Score (OHS)
Time frame: 5 years
Change from Baseline in Pain
Pain will be assessed with a Numeric Rating Scale (NRS)
Time frame: 2 years
Change from Baseline in Pain
Pain will be assessed with a Numeric Rating Scale (NRS)
Time frame: 5 years
Plan to share: No
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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