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

NCT06864897 | Recruiting FDA Device

• 1 other identifier: NL86542.100.24
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Dislocation

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (4)

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

  10 years

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

  10 years

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

  10 years

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

  10 years

Study Arms (2)

Polyethylene liner

Device: Total hip prosthesis

Ceramic liner

Device: Total hip prothesis

Interventions

Total hip prothesis DEVICE

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

Ceramic liner

Total hip prosthesis DEVICE

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

Polyethylene liner

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Enrolled in the initial Delta-TT trial

You may not qualify if:

• 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.

Sponsors & Collaborators

• JointResearch: lead

Study Sites (1)

OLVG Hospital

Amsterdam, North Holland, 1091 AC, Netherlands

RECRUITING

MeSH Terms

Conditions

Hip Dislocation

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Rudolf Poolman, PhD

  Orthopedic Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amdanda Klaassen, Msc

CONTACT

+3120 599 3653; A.D.Klaassen@olvg.nl

Okke Hoonhout

CONTACT

+3120 599 3653; o.hoonhout@olvg.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 7, 2025
• Study Start: October 10, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2029
• Last Updated: March 14, 2025

Record last verified: 2024-12

Locations

NL (1)