Osteoarthrosis Clinical Trial
— RSA-DELTA-TTOfficial title:
Early Stability of the Delta-TT Cup With Polyethylene Insert Compared to the Delta-TT Cup With Ceramic Insert. A Randomised RSA Study
NCT number | NCT03093038 |
Other study ID # | NL44230.100.13 - v1.0 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2014 |
Est. completion date | May 2021 |
Verified date | October 2021 |
Source | JointResearch |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | May 2021 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Patients scheduled to undergo primary total hip replacement. - Patient is able to understand the meaning of the study and is willing to sign the ethical committee approved, study-specific Informed Patient Consent Form. - Ability and willingness to follow instructions and to return for follow-up evaluations. - The subject is a male or non-pregnant female between 18 and 75 years of age. Exclusion Criteria: - The subject is morbidly obese, defined as Body Mass Index (BMI) of > 40. - The subject will be operated bilaterally. - Patients having a deformity or disease located in other joints than the hip that needs surgery and is limiting their ability to walk. - The subject has an active or suspected latent infection in or about the hip joint. - The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. - The subject has a systemic or metabolic disorder leading to progressive bone deterioration. - The subject's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. - Female patients planning a pregnancy during the course of the study. - The patient is unable or unwilling to sign the Informed Consent specific to this study. - Subject deemed unsuitable for participation in the study based on the investigator's judgement. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | Noord Holland |
Lead Sponsor | Collaborator |
---|---|
JointResearch |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | |
Secondary | Change from Baseline in Quality of Life | Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D) | 2 years | |
Secondary | Change from Baseline in Quality of Life | Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D) | 5 years | |
Secondary | 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) | 2 years | |
Secondary | 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) | 5 years | |
Secondary | Change from Baseline in Physical Function and Pain | Physical Function will be assessed with the Oxford Hip Score (OHS) | 2 years | |
Secondary | Change from Baseline in Physical Function and Pain | Physical Function will be assessed with the Oxford Hip Score (OHS) | 5 years | |
Secondary | Change from Baseline in Pain | Pain will be assessed with a Numeric Rating Scale (NRS) | 2 years | |
Secondary | Change from Baseline in Pain | Pain will be assessed with a Numeric Rating Scale (NRS) | 5 years |
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