ArthritisNCT02290652
Sexual Function Questionnaire Total Hip Replacement
An observational study of Arthritis, run by University Hospital Southampton NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
Non-commercial trial 2 Centres involved: University Hospital Southampton and Spire Southampton Expected number of eligible participants available per year: 100, (95% expected to agree to participation) The study will recruit prospectively female patients aged 18 - 65 years undergoing THR. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- Prospective - Factors affecting sexual function pre-THR and Retrospective- Factors affecting sexual function post-THR
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2014to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All female patients aged over 18 that are listed for a total hip replacement at University Hospital Southampton NHS Foundation Trust and The Spire Hospital Southampton that fulfill the inclusion criteria will be asked to participate.
Who may be able to join
- Female
- Sexually active
- Heterosexual
- 18- 65 years undergoing THR (prospective) or having undergone THR surgery within the last year
Who cannot join
- Sexually inactive pre-operatively and wishing to remain sexually inactive post-operatively
- Unable to comprehend English and with capacity to consent and follow instruction
- Unable to sign and date the ethics committee approved consent documentation
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Spire Southampton Hospital
Southampton, Hampshire, SO16 6UY
University of Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
About this study
Official title: Development and Validation of a Sexual Function Questionnaire for Female Patients Undergoing Total Hip Replacement
- Non-commercial trial
- 2 Centres involved: University Hospital Southampton and Spire Southampton
- Expected number of eligible participants available per year: 100, (95% expected to agree to participation)
- The study will recruit prospectively female patients aged 18 - 65 years undergoing THR. A retrospective series of similar patients who have had a hip replacement will also be recruited.
- This is a research project that will run over 2 years. Data from 200 patients will be collected and analysed:
Retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative' Version 1.3 11/07/14
Read more
Prospective 23 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Pre-operative' Version 1.3 11/07/14
This project is significant in exploring an area of Orthopaedic medicine that has been little discussed in the literature. Preliminary results of our questionnaires have already revealed patients have a great desire to know how hip replacement will affect sexual function. Components of the questionnaire look at details such as: reasonable time frames for returning to sexual activity, positions that may be undesirable following replacement and which may lead to dislocation, concurrent use of analgesia and psychosexual aspects of total hip replacement surgery. The ultimate objective is to provide patients with detailed information about what to expect after hip replacement surgery.
Read the detailed description
Prospective
Patients will be recruited from clinics at University Hospital Southampton and Spire Southampton Hospital. If they agree in principle to participate they will be provided with the Patient Information Sheet (PIS) and consent forms. Having completed the consent forms (one for participant to keep and one for the site file) participants are assigned an alphanumeric study number, which will be written at the top of all questionnaires and research paperwork completed. A form detailing demographic information will be filled out on recruitment to provide data for comparative quantitative analysis.
Prior to their operation, whether in hospital or by post (patient preference), they will complete a pre-operative ASFQ and FSFI questionnaire. These will be returned to the research team either in person (if completed by an inpatient) or returned in a pre-stamped addressed envelope. Copies of the National Joint Registry (NJR) data and PROMs will also be made and kept for evaluation alongside the questionnaire data. Patients will then complete the post-operative questionnaires and FSFI validated questionnaire at 6 and 12 months after their surgery. Questionnaires will be distributed to the patients in clinic at 6 months and sent to their home address at 12 months post-operatively (returned with stamped and addressed envelope).
Retrospective
Potential participant will be highlighted from previous inpatient list of patients eligible for participation. These patients will be contacted via telephone by a Good Clinical Practice (GCP) trained member of the research team member and invited to participate in the trial. If keen a PIS will be sent out to the patient's home address. The research team member will then follow-up with a phone-call to gain implied consent and complete an additional form detailing demographic information (the same information as the prospective cohort). The post-operative questionnaire, FSFI questionnaire and consent forms (one for participant to keep and one for the site file) with a stamped address envelope, will then be sent out to the participant to complete. Once documents are completed they will be returned to the research team. Questionnaires will be sent out at 6 and 12 months post-op where possible. Maximum time retrospective recruitment will be 12 months. The patient's NJR and PROMs will also be accessed for evaluation alongside the questionnaire data.
- Conditions
- Arthritis
- Being tested
- Prospective - Factors affecting sexual function pre-THR, Retrospective- Factors affecting sexual function post-THR
- Keywords
- Sexual function in Orthopaedic patients
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective - Factors affecting sexual function pre-THROther
A prospective assessment of factors affecting sexual function in patients whom are awaiting a total hip replacement.
Patients will carry out a prospective 23 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Pre-operative' with validated questionnaire Female Sexual Function Index (FSFI), before their operation.
Then at 6 months and 12 months post-operatively they will fill out a retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative', again with FSFI.
Retrospective- Factors affecting sexual function post-THROther
A retrospective assessment of factors affecting sexual function in patients whom have undergone a total hip replacement (THR) in the preceding year.
Patients will carry out a retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative' with validated questionnaire Female Sexual Function Index (FSFI), at 6 months and/or 12 months (wherever possible).
Maximum retrospective collection of data 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Prospective - Factors affecting sexual function pre-THR Receives: Other: Prospective - Factors affecting sexual function pre-THR | |
| Retrospective | Retrospective- Factors affecting sexual function post-THR Receives: Other: Retrospective- Factors affecting sexual function post-THR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors affecting sexual activity related to total hip replacement, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ)
To determine those patient and implant factors that affect sexual activity after hip replacement surgery. The study data will be used to publish an evidence-based patient information booklet that will be a standard reference for patients and healthcare professionals.
Measured: 2 years
Secondary outcomes (1)
Factors affecting sexual activity related to other joint replacement surgery, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ)
The study will be extended to collect data from patients with knee arthritis who undergo knee replacement surgery (partial and total), as well as the partners of patients with hip and knee replacements. The study will also be extended to patients who have pre-arthritic conditions such as femoro-acetabular impingement, who undergo arthroscopic procedures.
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna C D'Souza, BM BSc(Hons), Principal investigator, Research Fellow, UHS NHS FT.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290652
- Sponsor's protocol ID
- 12/SC/0296
- Status last verified
- Sep 2018
- First submitted
- 3 Nov 2014
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Sexual Function Questionnaire for Female Patients Undergoing Total Hip Replacement
- ClinicalTrials.gov ID
- NCT02290652
- Acronym / sponsor ID
- 12/SC/0296
- Conditions
- Arthritis
- Keywords
- Sexual function in Orthopaedic patients
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Non-commercial trial
- 2 Centres involved: University Hospital Southampton and Spire Southampton
- Expected number of eligible participants available per year: 100, (95% expected to agree to participation)
- The study will recruit prospectively female patients aged 18 - 65 years undergoing THR. A retrospective series of similar patients who have had a hip replacement will also be recruited.
- This is a research project that will run over 2 years. Data from 200 patients will be collected and analysed:
Retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative' Version 1.3 11/07/14
Prospective 23 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Pre-operative' Version 1.3 11/07/14
This project is significant in exploring an area of Orthopaedic medicine that has been little discussed in the literature. Preliminary results of our questionnaires have already revealed patients have a great desire to know how hip replacement will affect sexual function. Components of the questionnaire look at details such as: reasonable time frames for returning to sexual activity, positions that may be undesirable following replacement and which may lead to dislocation, concurrent use of analgesia and psychosexual aspects of total hip replacement surgery. The ultimate objective is to provide patients with detailed information about what to expect after hip replacement surgery.
Detailed description
Prospective
Patients will be recruited from clinics at University Hospital Southampton and Spire Southampton Hospital. If they agree in principle to participate they will be provided with the Patient Information Sheet (PIS) and consent forms. Having completed the consent forms (one for participant to keep and one for the site file) participants are assigned an alphanumeric study number, which will be written at the top of all questionnaires and research paperwork completed. A form detailing demographic information will be filled out on recruitment to provide data for comparative quantitative analysis.
Prior to their operation, whether in hospital or by post (patient preference), they will complete a pre-operative ASFQ and FSFI questionnaire. These will be returned to the research team either in person (if completed by an inpatient) or returned in a pre-stamped addressed envelope. Copies of the National Joint Registry (NJR) data and PROMs will also be made and kept for evaluation alongside the questionnaire data. Patients will then complete the post-operative questionnaires and FSFI validated questionnaire at 6 and 12 months after their surgery. Questionnaires will be distributed to the patients in clinic at 6 months and sent to their home address at 12 months post-operatively (returned with stamped and addressed envelope).
Retrospective
Potential participant will be highlighted from previous inpatient list of patients eligible for participation. These patients will be contacted via telephone by a Good Clinical Practice (GCP) trained member of the research team member and invited to participate in the trial. If keen a PIS will be sent out to the patient's home address. The research team member will then follow-up with a phone-call to gain implied consent and complete an additional form detailing demographic information (the same information as the prospective cohort). The post-operative questionnaire, FSFI questionnaire and consent forms (one for participant to keep and one for the site file) with a stamped address envelope, will then be sent out to the participant to complete. Once documents are completed they will be returned to the research team. Questionnaires will be sent out at 6 and 12 months post-op where possible. Maximum time retrospective recruitment will be 12 months. The patient's NJR and PROMs will also be accessed for evaluation alongside the questionnaire data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective | – | Other: Prospective - Factors affecting sexual function pre-THRProspective - Factors affecting sexual function pre-THR |
| Retrospective | – | Other: Retrospective- Factors affecting sexual function post-THRRetrospective- Factors affecting sexual function post-THR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All female patients aged over 18 that are listed for a total hip replacement at University Hospital Southampton NHS Foundation Trust and The Spire Hospital Southampton that fulfill the inclusion criteria will be asked to participate.
Key inclusion criteria (4 listed)
- Female
- Sexually active
- Heterosexual
- 18- 65 years undergoing THR (prospective) or having undergone THR surgery within the last year
Key exclusion criteria (3 listed)
- Sexually inactive pre-operatively and wishing to remain sexually inactive post-operatively
- Unable to comprehend English and with capacity to consent and follow instruction
- Unable to sign and date the ethics committee approved consent documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective - Factors affecting sexual function pre-THRA prospective assessment of factors affecting sexual function in patients whom are awaiting a total hip replacement. Patients will carry out a prospective 23 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Pre-operative' with validated questionnaire Female Sexual Function Index (FSFI), before their operation. Then at 6 months and 12 months post-operatively they will fill out a retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative', again with FSFI. | Other | Prospective |
| Retrospective- Factors affecting sexual function post-THRA retrospective assessment of factors affecting sexual function in patients whom have undergone a total hip replacement (THR) in the preceding year. Patients will carry out a retrospective 30 question questionnaire: 'Arthroplasty \& Sexual Function Questionnaire (ASFQ) - Post-operative' with validated questionnaire Female Sexual Function Index (FSFI), at 6 months and/or 12 months (wherever possible). Maximum retrospective collection of data 12 months. | Other | Retrospective |
Primary outcome
Factors affecting sexual activity related to total hip replacement, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ)
Time frame: 2 years
To determine those patient and implant factors that affect sexual activity after hip replacement surgery. The study data will be used to publish an evidence-based patient information booklet that will be a standard reference for patients and healthcare professionals.
1 secondary outcome
Factors affecting sexual activity related to other joint replacement surgery, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ)
Time frame: 2-5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanna C D'Souza, BM BSc(Hons) principal investigator
Research Fellow, UHS NHS FT.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by University Hospital Southampton NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factors affecting sexual activity related to total hip replacement, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.