Hip SurgeryTinT10NCT06033651
Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10) Levels
An observational study of Hip Surgery, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
Trial summary
Patients are to be approached to attend clinic who have been identified as being implanted with either a Lima Corporate Delta Revision TT, Delta One TT or the Delta Multihole Systems hip systems between 2011 and 2015, a minimum of 10 years since hip surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Surgery
- What is being tested?
- x-ray
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 14 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2011 and 2015.
Who may be able to join
- All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2011 and 2015.
Who cannot join
- Deceased patients Patients who have undergone a subsequent acetabular revision Patients that lack capacity Prisoners in the custody of HM Prison service or who are offenders supervised by the probation service in England or Wales.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10)
Patients are to be approached to attend clinic who have been identified as being implanted with either a Lima Corporate Delta Revision TT, Delta One TT or the Delta Multihole Systems hip systems between 2011 and 2015, a minimum of 10 years since hip surgery. They will be x-rayed (AP pelvis and a lateral view) and have a clinical review in clinic.
Read the detailed description
Since its popularisation in the 1960's, Hip replacements have become one of the NHS's highest volume procedures. Unfortunately, hip replacements can fail with on average 8,500 revision hip replacements being performed each year pre-covid(1). Often this is very complex with destruction of the normal anatomy leaving surgeons with a significant challenge in ensuring appropriate positioning of the socket within the confines of the patient's anatomy.
The Lima Corporate Delta systems are designed to help surgeons with this very problem by providing the option of a 'face changer' allowing surgeons to place a socket within a socket.
To allow for this function, the 'face changer' must connect with the acetabular cup (socket).
140 patients have been identified as having had this modular acetabular system implanted at the RJAH in 2012 \& 2014, going into 2015. The aim of this study is to therefore identify the survivorship of these implants at 10 years.
- Conditions
- Hip Surgery
- Being tested
- x-ray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
x-rayRadiation
Also called AP view of pelvis
AP view of pelvis
| Study group | Role | What they receive |
|---|---|---|
| Only 1 arm for the study | All participants shall receive the same treatment. Receives: Radiation: x-ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
The survivourship of the modular acetabular hip system at 10 years post-op
This study will be the largest study to look at the survivorship of this acetabular system. Survivorship will be to the point of revision and clinical outcome survivorship is to the point of radiological loosening and PROMs data collection.
Measured: Participants will be invited to attend a one time clinic visit, after which their participation in the study has ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start10 Apr 2025 (estimated)
- Primary completion14 May 2026 (estimated)
- Study completion14 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hip SurgeryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Robin Banerjee, Principal investigator, The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033651
- Sponsor's protocol ID
- RL1 879
- Acronym
- TinT10
- Status last verified
- Apr 2025
- First submitted
- 29 Aug 2023
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ben-Shlomo Y, Blom A, Boulton C, Brittain R, Clark E, Dawson-Bowling S, Deere K, Esler C, Espinoza O, Evans J, Goldberg A, Gregson C, Howard P, Jameson S, Jennison T, Judge A, Lawrence S, Lenguerrand E, Marques E, McCormack V, Newell C, Pegg D, Penfold C, Porter M, Price A, Reed M, Rees J, Royall M, Sayers A, Stonadge J, Swanson M, Taylor D, Toms A, Watts A, Whitehouse M, Wilkinson M, Wilton T, Young E. The National Joint Registry 19th Annual Report 2022 [Internet]. London: National Joint Registry; 2022 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK587525/
PubMed 36516281Liu TK, Liu SH, Chang CH, Yang RS. Concentration of metal elements in the blood and urine in the patients with cementless total knee arthroplasty. Tohoku J Exp Med. 1998 Aug;185(4):253-62. doi: 10.1620/tjem.185.253.
PubMed 9865472
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10)
- ClinicalTrials.gov ID
- NCT06033651
- Acronym / sponsor ID
- TinT10 / RL1 879
- Conditions
- Hip Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 14 May 2026 (estimated)
- Study completion
- 14 May 2026 (estimated)
- First posted
- 13 Sep 2023 (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.
Patients are to be approached to attend clinic who have been identified as being implanted with either a Lima Corporate Delta Revision TT, Delta One TT or the Delta Multihole Systems hip systems between 2011 and 2015, a minimum of 10 years since hip surgery. They will be x-rayed (AP pelvis and a lateral view) and have a clinical review in clinic.
Detailed description
Since its popularisation in the 1960's, Hip replacements have become one of the NHS's highest volume procedures. Unfortunately, hip replacements can fail with on average 8,500 revision hip replacements being performed each year pre-covid(1). Often this is very complex with destruction of the normal anatomy leaving surgeons with a significant challenge in ensuring appropriate positioning of the socket within the confines of the patient's anatomy.
The Lima Corporate Delta systems are designed to help surgeons with this very problem by providing the option of a 'face changer' allowing surgeons to place a socket within a socket.
To allow for this function, the 'face changer' must connect with the acetabular cup (socket).
140 patients have been identified as having had this modular acetabular system implanted at the RJAH in 2012 \& 2014, going into 2015. The aim of this study is to therefore identify the survivorship of these implants at 10 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Only 1 arm for the study | – | Radiation: x-rayAll participants shall receive the same treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2011 and 2015.
Key inclusion criteria (1 listed)
- All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2011 and 2015.
Key exclusion criteria (1 listed)
- Deceased patients Patients who have undergone a subsequent acetabular revision Patients that lack capacity Prisoners in the custody of HM Prison service or who are offenders supervised by the probation service in England or Wales.
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 |
|---|---|---|
| x-rayAlso: AP view of pelvisAP view of pelvis | Radiation | Only 1 arm for the study |
Primary outcome
The survivourship of the modular acetabular hip system at 10 years post-op
Time frame: Participants will be invited to attend a one time clinic visit, after which their participation in the study has ended.
This study will be the largest study to look at the survivorship of this acetabular system. Survivorship will be to the point of revision and clinical outcome survivorship is to the point of radiological loosening and PROMs data collection.
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 9 Apr 2025.
- Background: PubMed 36516281Ben-Shlomo Y, Blom A, Boulton C, Brittain R, Clark E, Dawson-Bowling S, Deere K, Esler C, Espinoza O, Evans J, Goldberg A, Gregson C, Howard P, Jameson S, Jennison T, Judge A, Lawrence S, Lenguerrand E, Marques E, McCormack V, Newell C, Pegg D, Penfold C, Porter M, Price A, Reed M, Rees J, Royall M, Sayers A, Stonadge J, Swanson M, Taylor D, Toms A, Watts A, Whitehouse M, Wilkinson M, Wilton T, Young E. The National Joint Registry 19th Annual Report 2022 [Internet]. London: National Joint Registry; 2022 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK587525/
- Background: PubMed 9865472Liu TK, Liu SH, Chang CH, Yang RS. Concentration of metal elements in the blood and urine in the patients with cementless total knee arthroplasty. Tohoku J Exp Med. 1998 Aug;185(4):253-62. doi: 10.1620/tjem.185.253.
- Individual participant dataSharing planned: No
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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.
Robin Banerjee principal investigator
The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Surgery, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust.
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 1 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: opening soon, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Julie Steen (+441691404418 ext. 4418, julie.steen@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The survivourship of the modular acetabular hip system at 10 years post-op (time frame: Participants will be invited to attend a one time clinic visit, after which their participation in the study has ended.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06033651, which also lists 2 linked publications.
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 9 Apr 2025.