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Sexual Function Questionnaire Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT02290652
Recruitment Status : Withdrawn
First Posted : November 14, 2014
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Southampton NHS Foundation Trust

Brief 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. 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.


Condition or disease Intervention/treatment
Arthritis Other: Prospective - Factors affecting sexual function pre-THR Other: Retrospective- Factors affecting sexual function post-THR

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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development and Validation of a Sexual Function Questionnaire for Female Patients Undergoing Total Hip Replacement
Study Start Date : October 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Group/Cohort Intervention/treatment
Prospective
Prospective - Factors affecting sexual function pre-THR
Other: Prospective - Factors affecting sexual function pre-THR

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
Retrospective- Factors affecting sexual function post-THR
Other: Retrospective- Factors affecting sexual function post-THR

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Factors affecting sexual activity related to other joint replacement surgery, as measured by the Arthroplasty & Sexual Function Questionnaire (ASFQ) [ Time Frame: 2-5 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • Female
  • Sexually active
  • Heterosexual
  • 18- 65 years undergoing THR (prospective) or having undergone THR surgery within the last year

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290652


Locations
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United Kingdom
Spire Southampton Hospital
Southampton, Hampshire, United Kingdom, SO16 6UY
University of Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust
Investigators
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Principal Investigator: Joanna C D'Souza, BM BSc(Hons) Research Fellow, UHS NHS FT.

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Responsible Party: University Hospital Southampton NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02290652     History of Changes
Other Study ID Numbers: 12/SC/0296
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Keywords provided by University Hospital Southampton NHS Foundation Trust:
Sexual function in Orthopaedic patients
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases