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NCT Number: NCT06864897

The 10-year Follow-up of the Delta-TT Trial.

This 10-year follow-up study aims to further investigate long-term migration patterns of the uncemented Delta-TT cup and H-MAX S stem, comparing outcomes between ceramic and polyethylene liners. Given the predictive value of early RSA migration patterns at the 2-year mark for identifying implants at risk of aseptic loosening, we hypothesize that the Delta-TT cup will demonstrate good stability at the 10-year postoperative mark. Besides, it is hypothesized that migration of Delta TT-cups is comparable between ceramic and polyethylene liners.

The primary objective of this study is to measure the long-term stability of the Delta TT cup, combined with either a ceramic or cross-linked polyethylene liner, by means of RSA at 10-years postoperatively.

Secondary objectives are to measure long-term stability of the H-MAX S stem, by means of RSA at 10-year postoperatively. Furthermore the study aims to measure implant survival rates and patient-reported outcomes for both the Delta-TT cup and H-MAX S stem, comparing outcomes between the ceramic and polyethylene group.

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Key information

Conditions

Hip Dislocation Hip Injuries Joint Diseases Joint Dislocations Musculoskeletal Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

OLVG Hospital

Amsterdam, North Holland, 1091 AC, Netherlands

Location status: Recruiting

Location contact

Amdanda Klaassen, Msc

CONTACT

[email protected]

Okke Hoonhout

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in the initial Delta-TT trial

Exclusion criteria

  • Patient is unable or unwilling to sign the Informed Consent specific to this study.
  • Patient is unsuitable for participation in the study based on the investigator's judgement.

Treatment and study plan

Total hip prothesis

Device

Total hip prothesis with a Delta-TT cup, H MAX S Stem and a ceramic liner

Total hip prosthesis

Device

Total hip prosthesis with a Delta TT cup, H MAX S stem and polyethylene liner

Primary outcomes

  1. Long-term (10-year) migration pattern of the Delta-TT cup compared between a ceramic and polyethylene liner.

    Time frame: 10 Years

    Measured in 3D translations and rotations by means of Radiostereometric X-ray images at 10-years postoperatively. Data will be summarized by treatment group. A mixed model analysis will be performed to assess cup migration, with liner type (polyethylene vs. ceramic) as the primary independent value. The primary outcome is the effect of the liner type on implant migration. Differences are considered significant for p-values below 0.05.

Secondary outcomes

  1. Long-term (10-year) migration pattern of the H-MAX S Stem compared between a ceramic and polyethylene liner.

    Time frame: 10 years

    Measured in 3D translations and rotations by means of Radiostereometric X-ray images at 10-years postoperatively. Data will be summarized by treatment group. A mixed model analysis will be performed to assess stem migration, with liner type (polyethylene vs. ceramic) as the primary independent value. The primary outcome is the effect of the liner type on implant migration. Differences are considered significant for p-values below 0.05.

  2. Implant survival of the Delta TT cup and H-MAX S stem.

    Time frame: 10 years

    Survival data will be collected from the Dutch Arthroplasty Register (LROI). The collected data includes: revision (yes/no), Reason for revision and survival in years. Differences in revision rates will be reported, but nog statistically tested since the study is not powered for survival analysis.

  3. Radiographic signs of osteolysis around the Delta-TT cup.

    Time frame: 10 years

    Radiolucent lines are examined on lateral and anteroposterior X-rays. A radiolucent line is defined as such if the maximum width is equal to or greater than 1 mm. Orthopeadic surgeons will assess the radiolucent lines and will be blinded for liner type (obscured by researcher). Radiolucent lines are assessed in the three acetabular zones defined by DeLee and Charnley. A Chi-square test is used to compare the numer of cases with one or more radiolucent lines between the polyethylene liner group and the ceramix liner group. If there are fewer than 10 observed cases with one or more radiolucent lines in one of the two groups, the Fisher's exact test is used, which is valid for all sample sizes.

  4. Radiographic signs of osteolysis around the H-Max S stem.

    Time frame: 10 years

    Radiolucent lines are examined on lateral and anteroposterior X-rays. A radiolucent line is defined as such if the maximum width is equal to or greater than 1 mm. Orthopeadic surgeons will assess the radiolucent lines and will be blinded for liner type (obscured by researcher). Radiolucent lines are assessed in the seven zones zones defined by Gruen. A Chi-square test is used to compare the numer of cases with one or more radiolucent lines between the polyethylene liner group and the ceramix liner group. If there are fewer than 10 observed cases with one or more radiolucent lines in one of the two groups, the Fisher's exact test is used, which is valid for all sample sizes.

Study contacts

Contact information is provided by the study sponsor or research team.

Amdanda Klaassen, Msc

CONTACT

[email protected]

+3120 599 3653

Okke Hoonhout

CONTACT

[email protected]

+3120 599 3653

Sponsors and collaborators

Lead sponsor

JointResearch

Other

Registry information

Official study title

The 10-year Follow-up of the Delta-TT Trial: Stability of the Delta-TT Cup with Polyethylene Insert Compared to the Delta-TT Cup with Ceramic Insert.

Acronym: RSA-10

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Mar 7, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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