Feasibility study of hybrid or cemented implants for total hip replacement
| ISRCTN | ISRCTN11097021 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11097021 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 271885 |
| Protocol serial number | CPMS 46257, IRAS 271885 |
| Sponsor | Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust |
| Funder | NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-0817-20012 |
- Submission date
- 30/10/2020
- Registration date
- 19/02/2021
- Last edited
- 10/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Current plain English summary as of 02/03/2022:
Background and study aims
The hip joint is made up of a ball and socket joint, with the ball being at the head of the thigh bone (femur) and the cup-shaped socket in the pelvic bone. A total hip replacement involves devices being surgically implanted to replace damaged bone within the hip joint and this study is interested in two of the most common types. One type is where both the stem in the thigh bone and the socket in the pelvic bone are cemented in place and the other is where the stem is cemented and the socket is uncemented (called a hybrid implant). Both types of implant are regularly used in similar numbers but little research had been done to establish if one is any better than the other. The aim of this small study is to see if patients who are undergoing hip replacement for osteoarthritis are willing to participate in a study to provide information on how well they consider their new hip to be functioning, and how it affects their day-to-day activities, so that the researchers can decide if a larger study will be achievable to see which implant is better.
Who can participate?
Patients aged 18 and above who are undergoing total hip replacement and for whom either of the study implants are suitable to be used (fully cemented or hybrid)
What does the study involve?
Participants will have the type of implant used selected at random and the researchers will collect information about the operation from clinical notes. At recruitment and 6 weeks and between 3-6 months after their operation participants will be asked to answer questionnaires about the effect their hip replacement has on their day-to-day activity and whether they have had to use NHS services. In addition to this, a mix of people made up of those who took part and those who declined to take part, as well as surgeons and healthcare professionals involved in recruitment and/or data collection, will be interviewed by researchers to learn how recruitment and data collection processes may be developed to improve these aspects in a future trial.
An analysis of cost to the NHS for the treatment of the arthritis and the hip replacement procedure itself will also be carried out. This will be done by comparing what health services (e.g. visits to GP) were required for the six months before and after the surgery.
What are the possible benefits and risks of participating?
The possible risks and benefits of taking part are no different to usual clinical care as the hip implants and study procedures are in line with routine care. Participants will be asked to complete a short set of questionnaires on three occasions (at recruitment and 6 weeks and between 3-6 months post-operation) and some participants, surgeons and healthcare professionals may also take part in interviews with researchers.
Where is the study run from?
Liverpool Clinical Trials Centre (UK)
When is the study starting and how long is it expected to run for?
May 2020 to April 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Tony Coffey
hiphop@liverpool.ac.uk
Previous plain English summary:
Background and study aims
The hip joint is made up of a ball and socket joint, with the ball being at the head of the thigh bone (femur) and the cup-shaped socket in the pelvic bone. A total hip replacement involves devices being surgically implanted to replace damaged bone within the hip joint and this study is interested in two of the most common types. One type is where both the stem in the thigh bone and the socket in the pelvic bone are cemented in place and the other is where the stem is cemented and the socket is uncemented (called a hybrid implant). Both types of implant are regularly used in similar numbers but little research had been done to establish if one is any better than the other. The aim of this small study is to see if patients who are undergoing hip replacement are willing to participate in a study to provide information on how well they consider their new hip to be functioning, and how it affects their day-to-day activities, so that the researchers can decide if a larger study will be achievable to see which implant is better.
Who can participate?
Patients aged 18 and above who are undergoing total hip replacement and for whom either of the study implants are suitable to be used (fully cemented or hybrid)
What does the study involve?
Participants will have the type of implant used selected at random and the researchers will collect information about the operation from clinical notes. At recruitment and 6 weeks and between 3-6 months after their operation participants will be asked to answer questionnaires about the effect their hip replacement has on their day-to-day activity and whether they have had to use NHS services. In addition to this, a mix of people made up of those who took part and those who declined to take part, as well as surgeons and healthcare professionals involved in recruitment and/or data collection, will be interviewed by researchers to learn how recruitment and data collection processes may be developed to improve these aspects in a future trial.
What are the possible benefits and risks of participating?
The possible risks and benefits of taking part are no different to usual clinical care as the hip implants and study procedures are in line with routine care. Participants will be asked to complete a short set of questionnaires on three occasions (at recruitment and 6 weeks and between 3-6 months post-operation) and some participants, surgeons and healthcare professionals may also take part in interviews with researchers.
Where is the study run from?
Liverpool Clinical Trials Centre (UK)
When is the study starting and how long is it expected to run for?
May 2020 to January 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Tony Coffey
hiphop@liverpool.ac.uk
Contact information
Scientific
Trial Coordinator
Liverpool Clinical Trials Centre
University of Liverpool
Block C, Waterhouse Building
1-5 Brownlow Street
Liverpool
L69 3GL
United Kingdom
| Phone | +44 (0)151 794 8929 |
|---|---|
| hiphop@liverpool.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized; Both; Design type: Treatment, Device, Surgery, Qualitative |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Feasibility study for a comparative trial of hybrid or cemented implants for total hip replacement. Hip arthroplasty with Hybrid Or cemented implants: Patient-reported outcomes (HipHOP) |
| Study acronym | HipHOP |
| Study objectives | The aim of this study is to establish the feasibility of performing a randomized controlled trial comparing patient-reported functional outcomes and cost-effectiveness of total hip arthroplasty using either a fully cemented or a hybrid total hip implant. |
| Ethics approval(s) | Approved 26/08/2020, HSC REC B (Office for Research Ethics Committees Northern Ireland (ORECNI), Customer Care & Performance Directorate, Lissue Industrial Estate West, 5 Rathdown Walk, Moira Road, Lisburn, BT28 2RF, UK; +44 (0)28 95361400 ; recb@hscni.net), ref: 20/NI/0096 |
| Health condition(s) or problem(s) studied | Total hip replacement for osteoarthritis |
| Intervention | Current intervention as of 02/03/2022: The design of this study incorporates both quantitative and qualitative data collection and analyses, referred to as Workstream 1 (WS1) and Workstream 2 (WS2), respectively. Workstream 1 is the randomized controlled trial comparing the two hip implants by Patient-Reported Outcome Measures (PROMS); a cost-utility analysis is also included in the PROMS. Workstream 2 is interviews with patients, surgeons and healthcare professionals, designed to obtain their thoughts on the randomized controlled trial. The study has been discussed with a PPI group. All patients that are approached, regardless of their decision to participate in Workstream 1, will also be invited to participate in Workstream 2 if they meet the eligibility criteria, on which further information is shown below. Those patients that participate in workstream one will be allocated at random to receive either a fully cemented hip joint (where both the stem and socked are cemented into place) or a hybrid hip joint (where just the stem is cemented and the body forms new bone to hold the socked). They will also be required to complete a portfolio of questionnaires (validated and bespoke) on three occasions. There are six questionnaires in total, though not all of them need to be completed on every occasion. The first occasion must be prior to them being randomized to the type of hip joint they will receive. If they complete the questionnaires on the day of their surgery, it must also be prior to them receiving any anaesthetic. The second occasion will be at their routine 6-week postoperative follow-up and the third occasion will be via post at between 3-6 months post operation. If the routine 6-week post-operative consultation if virtual (e.g. due to COVID-19), the questionnaires will be posted to the patient at that timepoint too. Patients will not need to make any extra visits to hospital than they would for standard care and each will be on study for between 3-6 months post-operatively. Workstream two will aim to recruit up to 30 patients, 20-30 surgeons and about 6 healthcare professionals to participate in interviews. Patient interviews will be conducted to gain an understanding of why they chose to participate in workstream one, or not, along with their experiences of being in the study or their perceptions of what it would entail and, in the case of decliners, what the barriers were that prevented them from doing taking part. These interviews will be conducted over the phone. For participants who also take part in workstream 1, these interviews will ideally take place between 2-4 weeks after the patient has undergone their surgery. For decliners, the interview will be arranged at a time convenient to the participant, which could be before or after surgery. Surgeons that practice at hospitals participating in Workstream 1 (both surgeons who are, and who are not, allowing their patients to be randomised to Workstream 1), and also at other sites that could be considered as recruiting centres for a larger trial will be approached to participate in the workstream two interviews. Initial approach will be made by the Chief Investigator. He will provide a participant information sheet to explain the study and introduce the qualitative researcher, based at the University of Manchester. The purpose of these interviews will be to understand their perceptions of the trial and equipoise, understand factors relating to willingness/unwillingness to take part in a trial, and to identify any other issues that could affect trial findings being implemented into practice. These interviews will be done over the phone. The third cohort of participants for Workstream 2 are healthcare professionals who approached patients to participate in workstream 1 of the study and/or were involved in data collection. The purpose of these interviews is to learn about their experiences in recruiting patients and collecting data, and to learn about any changes to the study that may be required to aid recruitment to the larger study. These interviews will be done over the phone. Previous interventions as of 27/07/2021: The design of this study incorporates both quantitative and qualitative data collection and analyses, referred to as Workstream 1 (WS1) and Workstream 2 (WS2), respectively. Workstream 1 is the randomized controlled trial comparing the two hip implants by Patient-Reported Outcome Measures (PROMS); a cost-utility analysis is also included in the PROMS. Workstream 2 is interviews with patients, surgeons and healthcare professionals, designed to obtain their thoughts on the randomized controlled trial. The study has been discussed with a PPI group. All patients that are approached, regardless of their decision to participate in Workstream 1, will also be invited to participate in Workstream 2 if they meet the eligibility criteria, on which further information is shown below. Those patients that participate in workstream one will be allocated at random to receive either a fully cemented hip joint (where both the stem and socked are cemented into place) or a hybrid hip joint (where just the stem is cemented and the body forms new bone to hold the socked). They will also be required to complete a portfolio of questionnaires (validated and bespoke) on three occasions. There are six questionnaires in total, though not all of them need to be completed on every occasion. The first occasion must be prior to them being randomized to the type of hip joint they will receive. If they complete the questionnaires on the day of their surgery, it must also be prior to them receiving any anaesthetic. The second occasion will be at their routine 6-week postoperative follow-up and the third occasion will be via post at between 3-6 months post operation. If the routine 6-week post-operative consultation if virtual (e.g. due to COVID-19), the questionnaires will be posted to the patient at that timepoint too. Patients will not need to make any extra visits to hospital than they would for standard care and each will be on study for between 3-6 months post-operatively. Workstream two will aim to recruit up to 30 patients, 20-30 surgeons and about 6 research nurses to participate in interviews. Patient interviews will be conducted to gain an understanding of why they chose to participate in workstream one, or not, along with their experiences of being in the study or their perceptions of what it would entail and, in the case of decliners, what the barriers were that prevented them from doing taking part. These interviews will be conducted over the phone. For participants who also take part in workstream 1, these interviews will ideally take place between 2-4 weeks after the patient has undergone their surgery. For decliners, the interview will be arranged at a time convenient to the participant, which could be before or after surgery. Surgeons that practice at hospitals participating in Workstream 1 (both surgeons who are, and who are not, allowing their patients to be randomised to Workstream 1), and also at other sites that could be considered as recruiting centres for a larger trial will be approached to participate in the workstream two interviews. Initial approach will be made by the Chief Investigator. He will provide a participant information sheet to explain the study and introduce the qualitative researcher, based at the University of Manchester. The purpose of these interviews will be to understand their perceptions of the trial and equipoise, understand factors relating to willingness/unwillingness to take part in a trial, and to identify any other issues that could affect trial findings being implemented into practice. These interviews will be done over the phone. The third cohort of participants for Workstream 2 are healthcare professionals who approached patients to participate in workstream 1 of the study and/or were involved in data collection. The purpose of these interviews is to learn about their experiences in recruiting patients and collecting data, and to learn about any changes to the study that may be required to aid recruitment to the larger study. These interviews will be done over the phone. Previous interventions: The design of this study incorporates both quantitative and qualitative data collection and analyses, referred to as Workstream 1 (WS1) and Workstream 2 (WS2), respectively. Workstream 1 is the randomized controlled trial comparing the two hip implants by Patient-Reported Outcome Measures (PROMS); a cost-utility analysis is also included in the PROMS. Workstream 2 is interviews with patients, surgeons and research nurses, designed to obtain their thoughts on the randomized controlled trial. The study has been discussed with a PPI group. All patients that are approached, regardless of their decision to participate in Workstream 1, will also be invited to participate in Workstream 2 if they meet the eligibility criteria, on which further information is shown below. Those patients that participate in workstream one will be allocated at random to receive either a fully cemented hip joint (where both the stem and socked are cemented into place) or a hybrid hip joint (where just the stem is cemented and the body forms new bone to hold the socked). They will also be required to complete a portfolio of questionnaires (validated and bespoke) on three occasions. There are six questionnaires in total, though not all of them need to be completed on every occasion. The first occasion must be prior to them being randomized to the type of hip joint they will receive. If they complete the questionnaires on the day of their surgery, it must also be prior to them receiving any anaesthetic. The second occasion will be at their routine 6-week postoperative follow-up and the third occasion will be via post at 6 months post-operation. If the routine 6-week post-operative consultation if virtual (e.g. due to COVID-19), the questionnaires will be posted to the patient at that timepoint too. Patients will not need to make any extra visits to hospital than they would for standard care and will each be on study for 6 months post-operatively (-1 month/+2 months). Workstream two will aim to recruit up to 30 patients, 20-30 surgeons and about 6 research nurses to participate in interviews. Patient interviews will be conducted to gain an understanding of why they chose to participate in workstream one, or not, along with their experiences of being in the study or their perceptions of what it would entail and, in the case of decliners, what the barriers were that prevented them from doing taking part. These interviews will be conducted over the phone. For participants who also take part in workstream 1, these interviews will take place between 2-4 weeks after the patient has undergone their surgery. For decliners, the interview will be arranged at a time convenient to the participant, which could be before or after surgery. Surgeons that practice at hospitals participating in Workstream 1 (both surgeons who are, and who are not, allowing their patients to be randomised to Workstream 1), and also at other sites that could be considered as recruiting centres for a larger trial will be approached to participate in the workstream two interviews. Initial approach will be made by the Chief Investigator. He will provide a participant information sheet to explain the study and introduce the qualitative researcher, based at the University of Manchester. The purpose of these interviews will be to understand their perceptions of the trial and equipoise, understand factors relating to willingness/unwillingness to take part in a trial, and to identify any other issues that could affect trial findings being implemented into practice. These interviews will be done over the phone. The third cohort of participants for Workstream 2 are research nurses who approached patients to participate in workstream 1 of the study and/or were involved in data collection. The purpose of these interviews is to learn about their experiences in recruiting patients and collecting data, and to learn about any changes to the study that may be required to aid recruitment to the larger study. These interviews will be done over the phone. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Current primary outcome measure as of 27/07/2021: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 27/07/2021: |
| Completion date | 30/04/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 89 |
| Key inclusion criteria | Workstream 1: 1. Age 18 years and above 2. Undergoing a primary total hip arthroplasty with either a fully cemented or hybrid implant* 3. Able to give informed consent prior to randomisation 4. Able to communicate in both written and spoken English * All implants and bone cements that are used must be CE marked and used in accordance with their intended use. There is no limitation as to the manufacturer of prostheses used and surgeons will continue to use the implants that they are familiar with. Furthermore, surgeons will be free to use whichever head/socket material and diameter they feel appropriate. The surgical approach, anaesthetic type, rehabilitation after surgery and other concomitant factors will be as per the surgeons’ normal care. These factors will be recorded Workstream 2: Patient sample: 5. Have been approached to take part in Workstream 1 Surgeon sample: 6. Consultant orthopaedic surgeon at a Workstream 1 site or a potential site for a future full trial Research nurse sample - Updated 27/07/2021: Healthcare professional sample: 7. Involved in recruiting to Workstream 1 and/or collecting patient self-reported data |
| Key exclusion criteria | Workstream 1: 1. Previous surgery to the hip joint 2. All procedures with an indication other than osteoarthritis 3. Patient requiring complex total hip arthroplasty surgery, specifically augmentation of the acetabulum (eg structural bone graft or metal augment) and/or shortening/de-rotational osteotomy of the femur at the time of surgery 4. Patients requiring bilateral simultaneous total hip arthroplasty 5. Vision impairment that precludes the completion of PROMS questionnaires Workstream 2: All participants: 6. Hearing impairment that precludes communication by standard telephone |
| Date of first enrolment | 06/01/2021 |
| Date of final enrolment | 31/07/2021 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Royal Albert Edward
Infirmary
Wigan Lane
Wigan
WN1 2NN
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
North Shields
NE29 8NH
United Kingdom
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Coupland 1 Building
Oxford Road
Manchester
M13 9PL
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 data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Other unpublished results | version 1.0 | 10/05/2022 | 10/05/2022 | No | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | version 1.0 | 10/05/2022 | 10/05/2022 | No | Yes |
| Protocol file | version v3.0 | 29/04/2021 | 27/07/2021 | No | No |
Additional files
- ISRCTN11097021_PROTOCOL_V3.0_29Apr21.pdf
- Protocol file
- ISRCTN11097021 HipHOP - Lay summary of results, V1.0 10May2022.pdf
- Plain English results
- ISRCTN11097021 HipHOP - Scientific summary of results, V1.0 10May2022.pdf
- Other unpublished results
Editorial Notes
10/05/2022: The plain English results summary and scientific results summaries were uploaded as additional files.
02/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2021 to 31/07/2021.
2. The overall trial end date has been changed from 31/01/2022 to 30/04/2022.
3. The scientific title has been changed from "Feasibility study for a comparative trial of hybrid or cemented implants for total hip replacement. Hip arthroplasty with Hybrid Or cemented implants: Patient-reported outcomes (HiPHOP)" to "Feasibility study for a comparative trial of hybrid or cemented implants for total hip replacement. Hip arthroplasty with Hybrid Or cemented implants: Patient-reported outcomes (HipHOP)".
4. The intervention has been updated.
5. The plain English summary has been updated.
6. The sponsor address has been updated.
27/07/2021: The following changes were made to the trial record:
1. The condition was changed from 'Total hip replacement for arthrosis' to 'Total hip replacement for osteoarthritis'.
2. The interventions, primary and secondary outcomes, inclusion criteria were updated.
3. The recruitment end date was changed from 30/06/2021 to 30/09/2021.
4. The overall trial end date was changed from 30/09/2021 to 31/01/2022.
5. The target number of participants was changed from 'Planned Sample Size: 106; UK Sample Size: 106' to 'Planned Sample Size: 89; UK Sample Size: 89'.
6. North Bristol NHS Trust was removed as a trial participating centre.
7. Uploaded protocol Version 3.0, 29 April 2021 (not peer reviewed).
22/02/2021: Internal review.
10/02/2021: Uploaded protocol Version 2.0, 04 November 2020 (not peer reviewed).
30/10/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).
