Persistent Pain After Hip Replacement

NCT05845177 | Completed

• 1 other identifier: P-2022-933
• Study Type: observational
• Target: 2,777
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a nationwide cross-sectional survey on pain and satisfaction after total hip arthroplasty (THA). Please find the full protocol uploaded on ClinicalTrials.gov

Conditions

Persistent Postsurgical Pain; Arthritis Hip; Neuropathic Pain; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Moderate/Severe persistent postsurgical pain

  The main outcome is the number of patients with moderate or severe persistent postsurgical pain in the operated hip, defined as patients with a numerical rating scale (NRS) score higher than 3. The NRS score was dichotomised for the primary outcome because this is more intuitively understood by patients and clinicians. This outcome will be reported as percentage of all patients with 95% confidence interval, which is calculated with assumed binomial distribution as p ± 1.96 √( (p (1 - p) ) / n)

  12-15 months postoperatively

Other Outcomes (11)

• How satisfied are you with the outcome of your hip replacement surgery? Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied, Very dissatisfied

  12-15 months postoperatively

• Knowing what your hip replacement surgery did for you, if you could go back in time, would you still have undergone this surgery? Yes, No, Uncertain

  12-15 months postoperatively

• Pain frequency: Do you still have pain in the operated hip? Yes, constantly; Yes, daily; Yes, a few times a week; Ja, more rarely; No

  12-15 months postoperatively

Interventions

Primary Total Hip Arthroplasty PROCEDURE

All patients surveyed have undergone primary total hip arthroplasty approximately 1 year prior to survey distribution

Also known as: Primary Total Hip Replacement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are identifed from the Danish National Patient Register through the Danish Health Data Authority (SKS-code DM16 \[hip osteoarthritis\] + KNFB \[Primary Total Hip Arthroplasty\]). Baseline data of respondents and non-respondents are gathered from the Danish Hip Arthroplasty Register.

You may qualify if:

• Patients operated with primary THA for osteoarthritis 12-15 months before survey distribution

You may not qualify if:

• Legally incompetent citizens, i.e., persons with a legal guardian, will not be asked to participate.

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead

Study Sites (1)

Bispebjerg University Hospital

Copenhagen, 2200, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative; Neuralgia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Søren Overgaard, MD, PhD, Professor

  Department of orthopedic surgery, Bispebjerg University Hospital, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: May 6, 2023
• Study Start: September 4, 2023
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)