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

Early Stability of the Delta-TT Cup With Polyethylene Insert Compared to the Delta-TT Cup With Ceramic Insert. A Randomised RSA Study

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthrosis
• Intervention / Treatment: Device: H-MAX stem & Delta-TT cup + polyethylene; Device: H-MAX stem & Delta-TT cup + ceramic; Device: C2 stem & Delta-TT cup + ceramic

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1090 hm
      • Onze Lieve Vrouwe Gasthuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: H-MAX stem & Delta-TT cup + polyethylene; H-MAX femoral stem and the Delta-TT cup with polyethylene insert	Device: H-MAX stem & Delta-TT cup + polyethylene; H-MAX femoral stem & Delta-TT cup with a polyethylene insert
EXPERIMENTAL: H-MAX stem & Delta-TT cup + ceramic; H-MAX femoral stem and the Delta-TT cup with ceramic insert	Device: H-MAX stem & Delta-TT cup + ceramic; H-MAX femoral stem & Delta Delta-TT cup with a Ceramic insert
EXPERIMENTAL: C2 stem & Delta-TT cup + ceramic; C2 femoral stem and the Delta-TT cup with ceramic insert	Device: C2 stem & Delta-TT cup + ceramic; C2 femoral stem Delta Delta-TT cup with a Ceramic insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Quality of Life	Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D)	2 years
Change from Baseline in Quality of Life	Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D)	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)	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)	5 years
Change from Baseline in Physical Function and Pain	Physical Function will be assessed with the Oxford Hip Score (OHS)	2 years
Change from Baseline in Physical Function and Pain	Physical Function will be assessed with the Oxford Hip Score (OHS)	5 years
Change from Baseline in Pain	Pain will be assessed with a Numeric Rating Scale (NRS)	2 years
Change from Baseline in Pain	Pain will be assessed with a Numeric Rating Scale (NRS)	5 years

Collaborators and Investigators

• Sponsor: JointResearch
• Investigators: Principal Investigator: Rudolf W Poolman, MD PhD, Onze Lieve Vrouwe Gasthuis

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2014
• Primary Completion (ACTUAL): February 1, 2018
• Study Completion (ACTUAL): May 1, 2021

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (ACTUAL): March 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: NL44230.100.13 - v1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO