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 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 276445 |
| Protocol serial number | CPMS 52086, H-I-121, IRAS 276445 |
| Sponsor | South Tees Hospitals NHS Foundation Trust |
| Funder | Stryker |
- Submission date
- 23/08/2023
- Registration date
- 25/08/2023
- Last edited
- 08/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
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 5 years. (1) Outpatient appointments: Participants will be required to attend outpatient appointments at 6-12 weeks, 1 year. The team will collect information on any issues and X-rays will also be taken during the 1-year appointment. (2) Questionnaires: Participants will be asked to complete questionnaires (at the appointment, over the telephone or via email) at 6-12 weeks, 1 year, and 5 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 October 2030
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
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised cohort study |
| Secondary study design | Non randomised study |
| 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 objectives | 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 |
| Health condition(s) or problem(s) studied | Total hip arthroplasty |
| Intervention | Current interventions as of 08/10/2025: Participants will undergo hip replacement surgery with a Trident® II 3D printed acetabular component. Patients will be included in the study for up to 6 years in total. Approximately a 12-month enrollment period, plus up to 5 years post-operative follow-up for each patient (6/12 weeks, 1 year, and 5 years). Previous Interventions: Participants will undergo hip replacement surgery with a 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(s) |
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 |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 08/10/2025: |
| Completion date | 31/10/2030 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 40 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 100 |
| Total final enrolment | 106 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 09/05/2022 |
| Date of final enrolment | 01/07/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 44169 Trident II PIS V1.2 09Mar2022.pdf
- Participant information sheet
Editorial Notes
08/10/2025: The following changes were made:
1. Completion date was changed from 01/07/2034 to 31/10/2030.
2. The interventions, secondary outcome measures and publication and dissemination plan were updated.
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).
