AzTrials
AzTrials

OsteoarthrosisRSA-DELTA-TTNCT03093038

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

A study testing H-MAX stem & Delta-TT cup + polyethylene, H-MAX stem & Delta-TT cup + ceramic and C2 stem & Delta-TT cup + ceramic in people with Osteoarthrosis, run by JointResearch at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Osteoarthrosis
What is being tested?
H-MAX stem & Delta-TT cup + polyethylene, H-MAX stem & Delta-TT cup + ceramic and C2 stem & Delta-TT cup + ceramic
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteNetherlands
Study dates
May 2014to May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam, North Holland, 1090 HM

Other trials in Netherlands

About this study

Official title: 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.

Read the 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
Being tested
H-MAX stem & Delta-TT cup + polyethylene, H-MAX stem & Delta-TT cup + ceramic, C2 stem & Delta-TT cup + ceramic
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • H-MAX stem & Delta-TT cup + polyethyleneDevice

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

  • H-MAX stem & Delta-TT cup + ceramicDevice

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

  • C2 stem & Delta-TT cup + ceramicDevice

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

Study groups in NCT03093038
Study groupRoleWhat they receive
H-MAX stem & Delta-TT cup + polyethyleneActive comparatorH-MAX femoral stem and the Delta-TT cup with polyethylene insert
Receives: Device: H-MAX stem & Delta-TT cup + polyethylene
H-MAX stem & Delta-TT cup + ceramicExperimentalH-MAX femoral stem and the Delta-TT cup with ceramic insert
Receives: Device: H-MAX stem & Delta-TT cup + ceramic
C2 stem & Delta-TT cup + ceramicExperimentalC2 femoral stem and the Delta-TT cup with ceramic insert
Receives: Device: C2 stem & Delta-TT cup + ceramic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

Secondary outcomes (8)

  1. Change from Baseline in Quality of Life

    Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D)

    Measured: 2 years

  2. Change from Baseline in Quality of Life

    Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D)

    Measured: 5 years

  3. 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)

    Measured: 2 years

  4. 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)

    Measured: 5 years

  5. Change from Baseline in Physical Function and Pain

    Physical Function will be assessed with the Oxford Hip Score (OHS)

    Measured: 2 years

  6. Change from Baseline in Physical Function and Pain

    Physical Function will be assessed with the Oxford Hip Score (OHS)

    Measured: 5 years

  7. Change from Baseline in Pain

    Pain will be assessed with a Numeric Rating Scale (NRS)

    Measured: 2 years

  8. Change from Baseline in Pain

    Pain will be assessed with a Numeric Rating Scale (NRS)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2017
  2. Study startMay 2014
  3. Primary completionFeb 2018
  4. Study completionMay 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03093038
Sponsor's protocol ID
NL44230.100.13 - v1.0
Acronym
RSA-DELTA-TT
Status last verified
Oct 2021
First submitted
17 Dec 2014
Last updated
13 Oct 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39160668

Questions about this trial

What is this clinical trial studying?

A study testing H-MAX stem & Delta-TT cup + polyethylene, H-MAX stem & Delta-TT cup + ceramic and C2 stem & Delta-TT cup + ceramic in people with Osteoarthrosis, run by JointResearch at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in stability (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03093038, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in