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

NCT06033651 | Not Yet Recruiting

• 1 other identifier: RL1 879
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will be invited to attend a one time clinic visit, after which their participation in the study has ended.

Study Arms (1)

Only 1 arm for the study

All participants shall receive the same treatment.

Radiation: x-ray

Interventions

x-ray RADIATION

AP view of pelvis

Also known as: AP view of pelvis

Only 1 arm for the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust: lead

Related 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/

  PMID: 36516281 BACKGROUND

• 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.

  PMID: 9865472 BACKGROUND

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Robin Banerjee

  The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Steen

CONTACT

+441691404418; julie.steen@nhs.net

Thomas Banks

CONTACT

+441691404418; thomas.banks3@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 13, 2023
• Study Start: April 10, 2025
• Primary Completion: May 14, 2026
• Study Completion: May 14, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share