A prospective clinical evaluation of the Trident II 3D printed acetabular component in total hip replacement patients
| ISRCTN | ISRCTN57876689 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57876689 |
| IRAS number | 276445 |
| Secondary identifying numbers | CPMS 52086, H-I-121, IRAS 276445 |
- Submission date
- 23/08/2023
- Registration date
- 25/08/2023
- Last edited
- 09/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
The hip is a ball and socket joint. The ball is at the top of your thigh bone, and the socket is part of your pelvic bone. In a total hip replacement (arthroplasty), both the ball and the socket will be replaced. The Trident® II acetabular component is a new implant that will be used to replace the socket of the hip aiming to offer patients a better range of movement, lower the risk of dislocation and a more stable joint. Trident implants are routinely used in South Tees hospital in patients who require a hip replacement. It is important to find out how the new Trident® II implant performs and how well patients are doing after surgery.
Who can participate?
People aged 40 to 75 who have issues with their hip joints like arthritis or injuries. Thesepeople should be willing and able to follow the doctor's orders after getting a new hip joint, and they should be okay with the idea of rehabilitation (exercise to get better). They must also be mentally ready and understand what they're signing up for. It's important that they don't have any major health problems that could interfere with the results.
What does the study involve?
Before surgery: This study will take place at South Tees Hospital NHS Foundation Trust, where their surgery and outpatient appointments would also take place. Eligible participants will be asked to read and understand a Participant Information Sheet and will be asked to sign an Informed Consent Form for the study. The research team will collect information from the participants medical notes, including x-rays. The team will also contact the participant via email or telephone to complete some questionnaires.
Surgery and hospital stay: The surgeon will perform the surgery using the Trident® II implant. The care the participant will receive in hospital will be the same as standard care. The research team will collect information from the participants medical notes about the surgery and hospital stay. X-rays will be taken before the participant leaves the hospital.
After surgery: The participant will be required to attend clinical appointments and receive additional x-rays as part of the enhanced follow-up process for up to 10 years. (1) Outpatient appointments: Participants will be required to attend outpatient appointments at 6-12 weeks, 1 year, 5 years and 10 years. The team will collect information on any issues and x-rays will also be taken during the 1 year, 5 year and 10 year appointments. (2) Questionnaires: Participants will be asked to complete questionnaires (at the appointment, over telephone or via email) at 6-12 weeks, 1 years, 3 years, 5 years, 7 years and 10 years.
What are the possible benefits and risks of participating?
Benefits of Trident II implant: A better range of movement, a lower risk of dislocation, a more stable joint compared to the standard component.
Benefits of a total hip replacement in general: Pain reduction, increased function, improved quality of life.
Risks of Trident II implant: The evidence from testing the Trident II acetabular component tells us that the risks are unlikely to be higher than the alternative options.
Risks of a total hip replacement in general: Failure of the implant due to a non-infection related cause (aseptic loosening of the prosthesis), infection, blood clot (deep vein thrombosis), post-operative pain, new bone in the soft tissues (heterotopic ossification), fracture of the implant or bone, loss of muscle function, dislocation, medical complications or death, leg length discrepancy, nerve and vessel injury.
Where is the study run from?
South Tees Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
March 2022 to July 2034
Who is funding the study?
Stryker (USA)
Who is the main contact?
Dr Lucksy Kottam, lucksy.kottam@nhs.net
Contact information
Scientific
Academic Centre for Surgery
James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
 ORCID ID |
0000-0002-9462-4425 |
|---|---|
| Phone | +44 1642 835764 |
| natalie.clark17@nhs.net |
Scientific
Academic Centre for Surgery
James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
| ORCID ID |
0000-0002-7976-2416 |
|---|---|
| Phone | +44 1642 854814 |
| lucksy.kottam@nhs.net |
Principal Investigator
South Tees Hospitals NHS Foundation Trust
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| Phone | +44 1642850850 |
|---|---|
| simonjameson@nhs.net |
Study information
| Study design | Non-randomised cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 44169 Trident II PIS V1.2 09Mar2022.pdf |
| Scientific title | Performance and function of the Trident® II 3D printed acetabular component |
| Study acronym | Trident® II 3D - South Tees |
| Study hypothesis | The risks of revision, re-operation and complications for a Trident II 3D printed acetabular component will be equivalent to other types of hybrid total hip replacement reported in the literature. The Trident II 3D printed acetabular component will demonstrate equivalent function and risk of dislocation compared to other types of hybrid total hip replacement reported in the literature. |
| Ethics approval(s) |
Approved 15/03/2022, South West - Central Bristol Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, United Kingdom; +44 2071048029; centralbristol.rec@hra.nhs.uk), ref: 22/SW/0024 |
| Condition | Total hip arthroplasty |
| Intervention | Participants will undergo hip replacement surgery with Trident® II 3D printed acetabular component. Patients will be included in the study for up to 11 years in total. Approximately a 12 month enrollment period, plus up to 10 years post-operative follow-up for each patient (6/12 weeks, 1 year, 3 years, 5 years, 7 years, 10 years). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Patient reported outcome measures (PROMs) assessing symptoms and functional limitations measured using the Oxford Hip Score (OHS) at baseline and at 1 year post-operatively 2. Device survivorship measured by clinical assessment (rates of re-operation and revision, including any adverse events) at 1 year post-operatively |
| Secondary outcome measures | 1. PROMs assessing symptoms and functional limitations measured using the Oxford Hip Score (OHS): pre-operative and 6-12 weeks, 1 year, 3 years, 5 years, 7 years and 10 years post-operative 2. PROMs assessing awareness of artificial joint in everyday life measured using the Forgotten Joint Score (FJS): pre-operative and 6-12 weeks, 1 year, 3 years, 5 years, 7 years and 10 years post-operative 3. PROMs assessing health outcome and quality of life measured using the EQ5D5L: pre-operative and 6-12 weeks, 1 year, 3 years, 5 years, 7 years and 10 years post-operative 4. Device survivorship measured by clinical assessment (rates of re-operation and revision, including any adverse events) prior to discharge (PTD), 6-12 weeks, 1 year, 5 years and 10 years post-operative. Radiographic assessment will also be collected as part of device survivorship and national recommendations of the British Orthopaedic Association (BOA) for follow-up of a new implant, collected: pre-operative, PTD, 1 year, 5 years and 10 years post-operative |
| Overall study start date | 15/03/2022 |
| Overall study end date | 01/07/2034 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| Total final enrolment | 106 |
| Participant inclusion criteria | 1. Male or non-pregnant female between 40 and 75 years of age with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN) or post-traumatic arthritis (PTA) and requiring primary THA and is suitable for the use for the uncemented Trident II acetabular component, in combination with any Stryker liner and any compatible femoral head and stem. 2. Patients who are physically and mentally willing and able to comply with the post-operative follow-ups and an appropriate rehabilitation schedule. 3. Patient is able to understand and provide written consent. 4. Patients with no clinically relevant disorders undergoing THA. |
| Participant exclusion criteria | 1. Patients deemed by the treating surgeon to be unable to comply with the prescribed post-operative routine and follow-up evaluation schedule. 2. Patients with rheumatoid arthritic hip as well as history of acetabular or femoral osteotomy. 3. Patients who have had a THA on the contra-lateral side within last 6 months. 4. Patients who are likely to need further lower limb joint replacement for another joint within one year. 5. Female patients between the ages of 40 and 75 years that are pregnant or planning a pregnancy up to 1 year during which they would have received the implant. 6. Patients who require revision of previously implanted THA. 7. Patients with active or suspected infection, requiring treatment. 8. Patients with active malignancy. 9. Patients diagnosed with systemic disease that would affect patient’s welfare or overall outcome of the study (severe osteoporosis, Paget’s Disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose. 10. Patients with a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient’s ability to limit weight bearing or places an extreme load on the implant during the healing period. 11. Patients with systemic or metabolic disorders leading to progressive bone deterioration (such as rickets, osteomalacia, osteogenesis, imperfecta, marble bone disease, (osteopetrosis), Paget disease of bone and fibrous dysplasia). 12. Patients with other concurrent illnesses which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus, psoriasis or renal disease requiring dialysis. 13. Patients with a body mass index (BMI), kg/m² > 40. Obese patients where obesity is severe enough to affect patient’s ability to perform activities of daily living. 14. Is the patient involved in a research study that, in the opinion of the PI, would affect their continued participation in the previous study and/or would affect the current study intervention and/or their treatment outcomes. |
| Recruitment start date | 09/05/2022 |
| Recruitment end date | 01/07/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Hospital/treatment centre
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom
| Phone | +44 1642 854089 |
|---|---|
| david.rollins@nhs.net | |
| Website | http://southtees.nhs.uk/ |
"ROR" |
https://ror.org/02js17r36 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Stryker Corporation
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/07/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | It is anticipated that a publication of the study results will be compiled and submitted to a high-impact peer-reviewed journal. There will be an interim analysis at 50 patients at 6-12 weeks post-operative, with further analysis of all patients at 1 year post-operative. We expect the first publication to be following the 3 year post-operative follow-up analysis. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 09/03/2022 | 24/08/2023 | No | Yes |
Additional files
Editorial Notes
09/09/2024: Total final enrolment added.
23/08/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
