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

March 12, 2025 updated by: JointResearch

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients enrolled in the initial Delta-TT trial are eligible for inclusion. These patients recieved a hip prothesis including a Delta-TT cup, a H-MAX S Stem and either a polyethylene or a ceramic Liner.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Polyethylene liner
Device: Total hip prosthesis
Total hip prosthesis with a Delta TT cup, H MAX S stem and polyethylene liner
Ceramic liner
Device: Total hip prothesis
Total hip prothesis with a Delta-TT cup, H MAX S Stem and a ceramic liner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years
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.
10 years
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.
10 years
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JointResearch

Investigators

  • Principal Investigator: Rudolf Poolman, PhD, Orthopedic Surgeon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL86542.100.24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hip Dislocation

Clinical Trials on Total hip prosthesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe