Persistent Postsurgical PainNCT06024161
Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties
An observational study of Persistent Postsurgical Pain and Arthritis Knee, run by Bispebjerg Hospital.
Trial summary
The study is a nationwide, register-based cohort survey study. The objective of this study is to investigate whether weight change is associated with the incidence of persistent postoperative pain following total hip arthroplasty and knee arthroplasty across non-obese and obese and patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Persistent Postsurgical Pain, Arthritis Knee, Arthropathy of Knee
- What is being tested?
- Weight gain, Weight loss and Weight unchanged
- How many people
- 6,400 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Nov 2024
- How long will I take part?
- 15 Months
- 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 99 years
- All sexes
- Adult, Older adult
Study population: Patients will be identified based on the NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures from the the Danish National Patient Register by using SKS-code the codes for THA patients will be SKS-code DM16 [hip osteoarthritis] + KNFB20 or KNFB30 or KNFB40[Primary Total Hip Arthroplasty]. For total knee arthroplasty (TKA), SKS-code DM17 [knee osteoarthritis] + KNGB20, KNGB30 or KNGB40 [primary total knee arthroplasty]. For medial unicompartmental knee arthroplasty (UKA), SKS-code DM17 [knee osteoarthritis] + KNGB01 or KNGB11 [primary medial unicompartmental knee arthroplasty].
Who may be able to join
- Patients operated with primary hip or knee arthroplasty for osteoarthritis 11-15 months before survey distribution
Who cannot join
- Legally incompetent citizens, i.e., persons with a legal guardian, will not be asked to participate.
Trial locations and contacts
No sites are listed yet.
Jens Laigaard, MD contact
About this study
Official title: Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties: A Nationwide Registry-based Cohort Survey Study.
The study is a nationwide, register-based cohort survey study. The objective of this study is to investigate whether weight change is associated with the incidence of persistent postoperative pain following total hip arthroplasty and knee arthroplasty across non-obese and obese and patients.
- Conditions
- Persistent Postsurgical Pain, Arthritis Knee, Arthropathy of Knee, Arthropathy of Hip, Weight Loss, Weight Gain
- Being tested
- Weight gain, Weight loss, Weight unchanged
- Medical subject headings
- Pain, Postoperative, Weight Loss, Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight gainOther
≥5% weight gain
Weight lossOther
≥5% weight loss after arthroplasty
Weight unchangedOther
<5% weight change after arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Weight gainers | Weight gain 11-15 months after arthroplasty Receives: Other: Weight gain | |
| Weight losers | Weight loss11-15 months after arthroplasty Receives: Other: Weight loss | |
| Weight unchanged | Weight unchanged 11-15 months after arthroplasty Receives: Other: Weight unchanged |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate/Severe Persistent Postoperative Pain
The primary outcome is the number of patients with moderate or severe persistent postsurgical pain in the operated hip or knee, defined as patients with a numerical rating scale (NRS) score higher than 3.
The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Measured: 11-15 months postsurgically
Secondary outcomes (6)
Satisfaction
Answering with "satisfied" or "very satisfied" in satisfaction question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Measured: 11-15 months postsurgically
Willingness to repeat the surgery
Answering "yes" in willlingness question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Measured: 11-15 months postsurgically
Frequent pain
Experiencing pain constantly, daily or few times a week The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Measured: 11-15 months postsurgically
Use of analgaesic
The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Measured: 11-15 months postsurgically
Interference with daily activities
Answering "some", "much" and "very much" in the interference question The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
Measured: 11-15 months postsurgically
WOMAC pain score
mean (standard deviaiton [SD]). We will report the mean difference (MD) and the corresponding 95% CI
Measured: 11-15 months postsurgically
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Postsurgical PainStudies 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
- Prospective
- Enrolment
- 6,400 participants (estimated)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saber Muthanna Saber, Bispebjerg Hospital
- Investigators
- Søren Overgaard, MD,DMSc,Prof, Study director, Department of orthopedic surgery, Bispebjerg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024161
- Sponsor's protocol ID
- p-2023-14578
- Status last verified
- Aug 2023
- First submitted
- 29 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties: A Nationwide Registry-based Cohort Survey Study.
- ClinicalTrials.gov ID
- NCT06024161
- Acronym / sponsor ID
- p-2023-14578
- Conditions
- Persistent Postsurgical Pain, Arthritis Knee, Arthropathy of Knee, Arthropathy of Hip, Weight Loss, Weight Gain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,400 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 6 Sep 2023 (actual)
- 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.
The study is a nationwide, register-based cohort survey study. The objective of this study is to investigate whether weight change is associated with the incidence of persistent postoperative pain following total hip arthroplasty and knee arthroplasty across non-obese and obese and patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Weight gainers | – | Other: Weight gainWeight gain 11-15 months after arthroplasty |
| Weight losers | – | Other: Weight lossWeight loss11-15 months after arthroplasty |
| Weight unchanged | – | Other: Weight unchangedWeight unchanged 11-15 months after arthroplasty |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified based on the NOMESCO (Nordic Medico-Statistical Committee) Classification of Surgical Procedures from the the Danish National Patient Register by using SKS-code the codes for THA patients will be SKS-code DM16 [hip osteoarthritis] + KNFB20 or KNFB30 or KNFB40[Primary Total Hip Arthroplasty]. For total knee arthroplasty (TKA), SKS-code DM17 [knee osteoarthritis] + KNGB20, KNGB30 or KNGB40 [primary total knee arthroplasty]. For medial unicompartmental knee arthroplasty (UKA), SKS-code DM17 [knee osteoarthritis] + KNGB01 or KNGB11 [primary medial unicompartmental knee arthroplasty].
Key inclusion criteria (1 listed)
- Patients operated with primary hip or knee arthroplasty for osteoarthritis 11-15 months before survey distribution
Key exclusion criteria (1 listed)
- Legally incompetent citizens, i.e., persons with a legal guardian, will not be asked to participate.
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 |
|---|---|---|
| Weight gain≥5% weight gain | Other | Weight gainers |
| Weight loss≥5% weight loss after arthroplasty | Other | Weight losers |
| Weight unchanged<5% weight change after arthroplasty | Other | Weight unchanged |
Primary outcome
Moderate/Severe Persistent Postoperative Pain
Time frame: 11-15 months postsurgically
The primary outcome is the number of patients with moderate or severe persistent postsurgical pain in the operated hip or knee, defined as patients with a numerical rating scale (NRS) score higher than 3. The outcome will be presented as Odd Ratio (OR) with its' corresponding 95% Confidence Interval (CI)
6 secondary outcomes
Satisfaction
Time frame: 11-15 months postsurgically
Willingness to repeat the surgery
Time frame: 11-15 months postsurgically
Frequent pain
Time frame: 11-15 months postsurgically
Use of analgaesic
Time frame: 11-15 months postsurgically
Interference with daily activities
Time frame: 11-15 months postsurgically
WOMAC pain score
Time frame: 11-15 months postsurgically
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
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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.
Jens Laigaard, MD contact
Søren Overgaard, MD,DMSc,Prof study director
Department of orthopedic surgery, Bispebjerg University Hospital, Denmark
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Postsurgical Pain and Arthritis Knee, run by Bispebjerg Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saber M. Saber, MD (004521299265, ssab0009@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate/Severe Persistent Postoperative Pain (time frame: 11-15 months postsurgically). 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 6 Sep 2023.