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NCT Number: NCT06033651

Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10) Levels

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2011 and 2015.

Exclusion criteria

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.

Treatment and study plan

X-Ray

Radiation

AP view of pelvis

Other names: AP view of pelvis

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Steen

CONTACT

[email protected]

+441691404418 ext. 4418

Thomas Banks

CONTACT

[email protected]

+441691404418

Sponsors and collaborators

Lead sponsor

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Other Gov

Registry information

Official study title

Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10)

Acronym: TinT10

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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