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

NCT03093038 | Completed

• 1 other identifier: NL44230.100.13 - v1.0
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthrosis

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (8)

• Change from Baseline in Quality of Life

  2 years

• Change from Baseline in Quality of Life

  5 years

• Change from Baseline in Physical Function

  2 years

• Change from Baseline in Physical Function

  5 years

• Change from Baseline in Physical Function and Pain

  2 years

Study Arms (3)

H-MAX stem & Delta-TT cup + polyethylene

ACTIVE COMPARATOR

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

Device: H-MAX stem & Delta-TT cup + polyethylene

H-MAX stem & Delta-TT cup + ceramic

EXPERIMENTAL

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

Device: H-MAX stem & Delta-TT cup + ceramic

C2 stem & Delta-TT cup + ceramic

EXPERIMENTAL

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

Device: C2 stem & Delta-TT cup + ceramic

Interventions

H-MAX stem & Delta-TT cup + polyethylene DEVICE

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

H-MAX stem & Delta-TT cup + polyethylene

H-MAX stem & Delta-TT cup + ceramic DEVICE

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

H-MAX stem & Delta-TT cup + ceramic

C2 stem & Delta-TT cup + ceramic DEVICE

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

C2 stem & Delta-TT cup + ceramic

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• JointResearch: lead

Study Sites (1)

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1090 HM, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39160668 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Rudolf W Poolman, MD PhD

  Onze Lieve Vrouwe Gasthuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2014
• First Posted: March 28, 2017
• Study Start: May 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: May 1, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)