Hip DislocationRSA-10NCT06864897
The 10-year Follow-up of the Delta-TT Trial.
An observational study of Hip Dislocation, run by JointResearch at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Dislocation
- What is being tested?
- Total hip prothesis and Total hip prosthesis
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Oct 2024to 1 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Enrolled in the initial Delta-TT trial
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
OLVG Hospital
Amsterdam, North Holland, 1091 AC
Amdanda Klaassen, Msc, A.D.Klaassen@olvg.nl
Okke Hoonhout, o.hoonhout@olvg.nl
About this study
Official 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.
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
- Being tested
- Total hip prothesis, Total hip prosthesis
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total hip prothesisDevice
Total hip prothesis with a Delta-TT cup, H MAX S Stem and a ceramic liner
Total hip prosthesisDevice
Total hip prosthesis with a Delta TT cup, H MAX S stem and polyethylene liner
| Study group | Role | What they receive |
|---|---|---|
| Polyethylene liner | Not described Receives: Device: Total hip prosthesis | |
| Ceramic liner | Not described Receives: Device: Total hip prothesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 Years
Secondary outcomes (4)
Long-term (10-year) migration pattern of the H-MAX S Stem 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 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.
Measured: 10 years
Implant survival of the Delta TT cup and H-MAX S stem.
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.
Measured: 10 years
Radiographic signs of osteolysis around the Delta-TT cup.
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.
Measured: 10 years
Radiographic signs of osteolysis around the H-Max S stem.
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start10 Oct 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JointResearch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudolf Poolman, PhD, Principal investigator, Orthopedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864897
- Sponsor's protocol ID
- NL86542.100.24
- Acronym
- RSA-10
- Status last verified
- Dec 2024
- First submitted
- 25 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06864897
- Acronym / sponsor ID
- RSA-10 / NL86542.100.24
- Conditions
- Hip Dislocation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- JointResearchUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyethylene liner | – | Device: Total hip prosthesis |
| Ceramic liner | – | Device: Total hip prothesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Enrolled in the initial Delta-TT trial
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total hip prothesisTotal hip prothesis with a Delta-TT cup, H MAX S Stem and a ceramic liner | Device | Ceramic liner |
| Total hip prosthesisTotal hip prosthesis with a Delta TT cup, H MAX S stem and polyethylene liner | Device | Polyethylene liner |
Primary outcome
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.
4 secondary outcomes
Long-term (10-year) migration pattern of the H-MAX S Stem compared between a ceramic and polyethylene liner.
Time frame: 10 years
Implant survival of the Delta TT cup and H-MAX S stem.
Time frame: 10 years
Radiographic signs of osteolysis around the Delta-TT cup.
Time frame: 10 years
Radiographic signs of osteolysis around the H-Max S stem.
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rudolf Poolman, PhD principal investigator
Orthopedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Dislocation, run by JointResearch at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amdanda Klaassen, Msc (+3120 599 3653, A.D.Klaassen@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term (10-year) migration pattern of the Delta-TT cup compared between a ceramic and polyethylene liner. (time frame: 10 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.