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

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ClinicalTrials.gov Identifier: NCT03093038
Recruitment Status : Active, not recruiting
First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
JointResearch

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.


Condition or disease Intervention/treatment Phase
Osteoarthrosis Device: H-MAX stem & Delta-TT cup + polyethylene Device: H-MAX stem & Delta-TT cup + ceramic Device: C2 stem & Delta-TT cup + ceramic Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : May 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change from Baseline in stability [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Change from Baseline in Quality of Life [ Time Frame: 2 years ]
    Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D)

  2. Change from Baseline in Quality of Life [ Time Frame: 5 years ]
    Quality of Life (QoL) will be assessed with the questionaire EuroQoL 5D (EQ- 5D)

  3. Change from Baseline in Physical Function [ Time Frame: 2 years ]
    Physical Function will be assessed with the Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS)

  4. Change from Baseline in Physical Function [ Time Frame: 5 years ]
    Physical Function will be assessed with the Hip disability and Osteoarthritis Outcome Score - Physical Function Short Form (HOOS-PS)

  5. Change from Baseline in Physical Function and Pain [ Time Frame: 2 years ]
    Physical Function will be assessed with the Oxford Hip Score (OHS)

  6. Change from Baseline in Physical Function and Pain [ Time Frame: 5 years ]
    Physical Function will be assessed with the Oxford Hip Score (OHS)

  7. Change from Baseline in Pain [ Time Frame: 2 years ]
    Pain will be assessed with a Numeric Rating Scale (NRS)

  8. Change from Baseline in Pain [ Time Frame: 5 years ]
    Pain will be assessed with a Numeric Rating Scale (NRS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093038


Locations
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Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, Noord Holland, Netherlands, 1090 HM
Sponsors and Collaborators
JointResearch
Investigators
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Principal Investigator: Rudolf W Poolman, MD PhD Onze Lieve Vrouwe Gasthuis

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Responsible Party: JointResearch
ClinicalTrials.gov Identifier: NCT03093038     History of Changes
Other Study ID Numbers: NL44230.100.13 - v1.0
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases