Long Term Follow up of the Titanium Modular Revision Hip System, With Review of Metal Ion Levels

Hip Surgery Clinical Trial

— TinT10  

Official title:

Long Term Follow up of the Titanium Modular Revision Hip System, With Review of Metal Ion Levels

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06033651
• Other study ID #: version 1 27/6/2023
• Status: Not yet recruiting
• Start date: May 30, 2024
• Est. completion date: May 30, 2025

Study information

• Verified date: April 2024
• Source: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
• Contact: Julie Steen
• Phone: +441691404418
• Email: julie.steen[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical 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 2013, a minimum of 10 years since hip surgery. They will be x-rayed (AP pelvis and a lateral view) and a blood test will be taken and sent to a lab in Surrey to check titanium levels.

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. 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 Revision TT, Delta One TT and Delta Multihole 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). Through research, it is widely known that when metals interact within the body, they can cause wear and shedding of metal debris. This process is known as metallosis and can result in metal ions being released into the surrounding bone and tissues as well as being absorbed into the blood stream.

The risk of this is highest when there is significant movement between the components (such as in metal-on-metal hip replacements). It is less of an issue at other interfaces which are not intended to allow movement between them. That said, our hypothesis is that the increase in the number of interfaces which gives us the flexibility we need, may increase the release of free metal ions in the blood stream. The aim of this study is to therefore identify if this is in fact the case and if so, whether the increase in ions is sufficient for surgeons to bear in mind.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2012 and 2013.

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.

Related Conditions & MeSH terms

• Hip Surgery

Intervention

Radiation:
• x-ray
A sample of blood will be taken and sent to a lab in Surrey to check for metal ions.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

References & Publications (2)

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/ — View Citation

Liu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The survivourship of the modular acetabular hip system at 10 years post-op	By looking at titanium ion blood levels and pelvis x-rays, this gives an indication of whether the device is loosening and failing in this particular hip system.	Once blood results are back from the specialist assessment laboratory (approximately 3 weeks post clinic visit).