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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2021
Source JointResearch
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
H-MAX stem & Delta-TT cup + polyethylene
H-MAX femoral stem & Delta-TT cup with a polyethylene insert
H-MAX stem & Delta-TT cup + ceramic
H-MAX femoral stem & Delta Delta-TT cup with a Ceramic insert
C2 stem & Delta-TT cup + ceramic
C2 femoral stem Delta Delta-TT cup with a Ceramic insert

Locations

Country Name City State
Netherlands Onze Lieve Vrouwe Gasthuis Amsterdam Noord Holland

Sponsors (1)

Lead Sponsor Collaborator
JointResearch

Country where clinical trial is conducted

Netherlands, 

Outcome

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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