Clinical trial NCT06033651: Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10) Levels
Official title: Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hip Surgery
Lead sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Sponsor class: OTHER_GOV
First posted: 2023-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2011 and 2015.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The survivourship of the modular acetabular hip system at 10 years post-op
timeFrame: Participants will be invited to attend a one time clinic visit, after which their participation in the study has ended.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust
name: Robin Banerjee
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/
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.