Early Stability of the Delta-TT Cup With Polyethylene Insert Versus a Ceramic Insert. A RSA Study.

NCT ID: NCT03093038

Last Updated: 2021-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2021-05-31

Brief 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.

Detailed 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.

Conditions

Osteoarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

H-MAX stem & Delta-TT cup + polyethylene

H-MAX femoral stem and the Delta-TT cup with polyethylene insert

Group Type: ACTIVE_COMPARATOR

H-MAX stem & Delta-TT cup + polyethylene

Intervention Type: DEVICE

H-MAX femoral stem \& Delta-TT cup with a polyethylene insert

H-MAX stem & Delta-TT cup + ceramic

H-MAX femoral stem and the Delta-TT cup with ceramic insert

Group Type: EXPERIMENTAL

H-MAX stem & Delta-TT cup + ceramic

Intervention Type: DEVICE

H-MAX femoral stem \& Delta Delta-TT cup with a Ceramic insert

C2 stem & Delta-TT cup + ceramic

C2 femoral stem and the Delta-TT cup with ceramic insert

Group Type: EXPERIMENTAL

C2 stem & Delta-TT cup + ceramic

Intervention Type: DEVICE

C2 femoral stem Delta Delta-TT cup with a Ceramic insert

Interventions

H-MAX stem & Delta-TT cup + polyethylene

H-MAX femoral stem \& Delta-TT cup with a polyethylene insert

Intervention Type: DEVICE

H-MAX stem & Delta-TT cup + ceramic

H-MAX femoral stem \& Delta Delta-TT cup with a Ceramic insert

Intervention Type: DEVICE

C2 stem & Delta-TT cup + ceramic

C2 femoral stem Delta Delta-TT cup with a Ceramic insert

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JointResearch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rudolf W Poolman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Onze Lieve Vrouwe Gasthuis

Locations

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, Netherlands

Countries

Netherlands

References

Klaassen AD, van Loon J, Willigenburg NW, Koster LA, Kaptein BL, van der Hulst VPM, Haverkamp D, Moojen DJF, Poolman RW. Comparison of 5-year cup and stem migration between ceramic-on-ceramic and ceramic-on-polyethylene bearing in press-fit total hip arthroplasty: a randomised controlled trial using radiostereometric analysis. Hip Int. 2024 Nov;34(6):701-716. doi: 10.1177/11207000241265653. Epub 2024 Aug 19.

Reference Type: DERIVED

PMID: 39160668 (View on PubMed)

Other Identifiers

NL44230.100.13 - v1.0

Identifier Type: -

Identifier Source: org_study_id