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

NCT ID: NCT06864897

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-10

Study Completion Date

2029-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Dislocation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Polyethylene liner

Total hip prosthesis

Intervention Type DEVICE

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

Ceramic liner

Total hip prothesis

Intervention Type DEVICE

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

Interventions

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Total hip prothesis

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

Intervention Type DEVICE

Total hip prosthesis

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JointResearch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rudolf Poolman, PhD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Surgeon

Locations

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OLVG Hospital

Amsterdam, North Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Amdanda Klaassen, Msc

Role: CONTACT

+3120 599 3653

Okke Hoonhout

Role: CONTACT

+3120 599 3653

Facility Contacts

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Amdanda Klaassen, Msc

Role: primary

Okke Hoonhout

Role: backup

Other Identifiers

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NL86542.100.24

Identifier Type: -

Identifier Source: org_study_id

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