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Rib FracturesPAROSNCT04745520

Randomized Clinical Trial of Rib Fixation Versus Medical Analgesia in Uncomplicated Rib Fractures on Pain Control.

A study testing Rib fixation and Analgesia in people with Rib Fractures, run by Benoît Bédat at 1 site in Switzerland.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Uncomplicated costal fractures often result in persistent pain over the long term. Indeed, cohort studies showed that at 6 months, 22% of patients still had pain and 56% had functional disability. The impact of costal fractures on quality of life is underestimated. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rib Fractures
What is being tested?
Rib fixation and Analgesia
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteSwitzerland
Study dates
12 Mar 2021to 16 Sep 2024
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 2 rib fractures
  • At least 1 dislocated rib fracture
  • Fractures accessible to surgery
  • Thoracic trauma no more than two days prior to screening for inclusion
  • Thoracic epidural analgesia
  • Written informed consent

Who cannot join

  • Any other concomitant fractures excepted clavicle fracture
  • Respiratory distress syndrome according to the Berlin definition
  • Presence of >1.5 liter of blood drained from the pleural space
  • Hemostasis disorder defined by any of the following criteria:
  • Platelet count < 70'000/mm3,
  • International Normalized Ratio (INR) > 1.2 (Prothrombin < 70%)
Show all 16Show fewer
  • activated partial thromboplastin time (aPTT) ≥ 60 seconds
  • drugs such as: P2Y12 antagonists (clopidogrel, prasugrel) and glycoprotein IIb/IIIa antagonists (abciximab, tirofiban)
  • Pathological rib fracture due to metastasis
  • Hemodynamic instability: systolic blood pressure < 100 mmHg and heart rate > 100 beats per minute
  • Neurologic disorder: Glasgow Coma Score < 13 in the initial 24 hours, or intracerebral, epidural, subdural, or subarachnoid hemorrhages, or cerebral contusion
  • Titanium allergy
  • Known or suspected non-compliance to medical therapy due to drug or alcohol abuse
  • Age <18 years old
  • Women who know they are pregnant or breast feeding
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Unit of Thoracic and Endocrine Surgery, University Hospitals of Geneva

    Geneva, 1205

Other trials in Switzerland

About this study

Official title: Comparison of Rib Fixation with Medical Analgesia in Patients with Uncomplicated Rib Fractures on Pain Control: a Multi-center Randomized Clinical Trial

Uncomplicated costal fractures often result in persistent pain over the long term. Indeed, cohort studies showed that at 6 months, 22% of patients still had pain and 56% had functional disability. The impact of costal fractures on quality of life is underestimated. The socio-psycho-economic consequences are substantial.

Previous studies have shown that an important factor for persistent pain and functional disability is the intensity of the initial pain. However, preliminary studies have shown promising results with surgical fixation of rib fractures: reduced need for analgesic drugs, reduced pain at 1 month, reduced complications and improved motor skills in patients over 65 years of age.

Read more

To date, the only clinical trials that exist focused on the fixation of complicated rib dislocations. While fixation of uncomplicated rib fractures is a common practice, no randomized studies have been conducted to evaluate its impact on pain and quality of life in the medium and long term.

In this context, the aim of our randomized study is to compare pain at 2 months between operated and non-operated patients with uncomplicated rib fractures.

Read the detailed description

Background. Until recently, functional disability and chronic pain and following uncomplicated rib fractures have been scarcely studied. Studies described persistent pain and disability in, respectively, 59% and 76% of patients at two months, and in 22% and 53% of patients at 6 months. In a retrospective study including 216 patients with an isolated thoracic injury, only 34.2% of patients had a good recovery at one year and the six-month return to work rate is of 63%. Persistent pain and disability following rib fractures therefore result in a large psycho-socio-economic impact for health-care system. The only predictive factor for persistent pain and disability is the pain intensity within the first few days after injury. Similarly, the intensity of pain within the first days after thoracotomy predicts long-term post-thoracotomy pain. In a recent meta-analysis, epidural analgesia provides better acute pain relief than intravenous, paravertebral, and intercostal interventions. While meta-analyses conclude that operative fixation of complicated flail chest provide better outcome, the impact of surgery on pain in uncomplicated rib fracture is seldom studied. Some retrospective studies showed promising results of rib fixation with surgery in patients with uncomplicated rib fractures: A study showed that rib fixation reduced postoperative analgesic requirements. Similarly, another study showed that pain was significantly reduced one month after surgery as compared to a non-surgical approach. Finally, it has been recently observed a decreased mortality and respiratory complications after surgery in patients over 65 years old as well as a better functional status at two weeks, two months, and four months.

Trial objectives. No previous studies have provided definitive evidence for recommending rib fixation over simple pain medication to control pain. Our hypothesis is that a surgical approach may have further benefits as compared to a conservative treatment. The primary objective of the study is to compare pain two months after injury between two groups: group 1) patients who are treated with surgery and analgesic treatment; and group 2) patients who are treated with analgesic treatment alone. The secondary objective is to perform a longitudinal analysis over one year of the following parameters: amount of pain medication, quality of life, anxiety and depression, pulmonary capacity, return to work, and adverse events. Financial aspects are also investigated.

Conditions
Rib Fractures
Being tested
Rib fixation, Analgesia
Keywords
thoracic trauma, rib fixation, medical device
Medical subject headings
Rib Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rib fixationDevice

    Rib fixation is performed by a senior surgeon. The patient is under general anesthesia. A thoracotomy focused on the fracture is performed to optimize access to the rib to be repaired. Video-assisted thoracic surgery (VATS) can be performed to better localize rib fractures. Significant muscle division is avoided. Removal of the periosteum is not required. The broken rib segments are approximated with forceps and the medical devices are used to fix the fracture. The medical devices are implemented according to the manufacturers' recommendations. The goal is to stabilize the chest wall. It is not useful to fix all fractures to stabilize the wall. A chest tube can be placed at the end of the operation.

    Medical devices

    The following medical devices can be used:

    • MatrixRIB™, De Puy Synthes Companies, Zuchwill, Switzerland
    • STRATOS™, MedXpert GmbH, Heitersheim, Germany
    • NiTi Fixing PlatesTM, IAWAI, Yandzhou, China

  • AnalgesiaDrug

    Epidural analgesia is continuing for 24 to 72 hours post-randomization to maximize outcome benefits. Afterwards, paracetamol, NSAID and/or opioid treatment are used according to pain severity. In case of opioid use, morphine treatment is preferred. However, other opioid drugs or doses can be considered to better customize the treatment.

Study groups in NCT04745520
Study groupRoleWhat they receive
Rib fixation (medical devices)ExperimentalSurgery and pain medication. The pain of patients will be treated with rib fixation and pain medication.
Receives: Device: Rib fixation; Drug: Analgesia
Pain medication (comparator treatment)Active comparatorPain medication only.
Receives: Drug: Analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain severity

    Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain

    Measured: Two months after injury

Secondary outcomes (41)

  1. Pain severity

    Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain

    Measured: At recruitment (baseline)

  2. Pain severity

    Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain

    Measured: One month after injury

  3. Pain severity

    Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain

    Measured: Three months after injury

  4. Pain severity

    Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain

    Measured: Six months after injury

  5. Pain severity

    Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain

    Measured: Twelve months after injury

  6. Anxiety and Depression.

    hospital anxiety and depression scale (HADS). Score 0-21. 21 = severe depression or anxiety

    Measured: At recruitment (baseline)

  7. Anxiety and Depression.

    hospital anxiety and depression scale (HADS). Score 0-21. 21 = severe depression or anxiety

    Measured: One month after injury

  8. Anxiety and Depression.

    hospital anxiety and depression scale (HADS). Score 0-21. 21 = severe depression or anxiety

    Measured: Two months after injury

  9. Neuropathic pain

    The French questionnaire "Douleur Neuropathique en 4 Questions (DN4)" is completed by an investigator during follow-up visits. The DN4 questionnaire was developed to diagnose polyneuropathy. Three items are linked with neuropathic pain examination, and seven items to pain symptoms. Score 0-10. Score >4 indicates neuropathic pain.

    Measured: Two months after injury

  10. Neuropathic pain

    The French questionnaire "Douleur Neuropathique en 4 Questions (DN4)" is completed by an investigator during follow-up visits. The DN4 questionnaire was developed to diagnose polyneuropathy. Three items are linked with neuropathic pain examination, and seven items to pain symptoms. Score 0-10. Score >4 indicates neuropathic pain.

    Measured: Six months after injury

  11. Pain interference

    The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.

    Measured: At recruitment (baseline)

  12. Pain interference

    The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.

    Measured: One month after injury

  13. Pain interference

    The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.

    Measured: Two months after injury

  14. Pain interference

    The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.

    Measured: Three months after injury

  15. Pain interference

    The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.

    Measured: Six months after injury

  16. Pain interference

    The last items of the BPI questionnaires measure how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others and sleep. BPI pain interference is scored as the mean of the seven items. Score 0-10. 10 = high interference of pain with activities.

    Measured: Twelve months after injury

  17. Health and well being

    The 36-Item Health Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Score: 0-100. 100 = better functioning

    Measured: At recruitment (baseline)

  18. Health and well being

    The 36-Item Health Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Score: 0-100. 100 = better functioning

    Measured: Two months after injury

  19. Health and well being

    The 36-Item Health Survey (SF-36) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Score: 0-100. 100 = better functioning

    Measured: Six months after injury

  20. Analgesic medication during hospitalisation

    During hospitalization, each day since the enrolment, amount and type of analgesic medication are recorded from the computerized patient record system.

    Measured: At recruitement (baseline)

  21. Analgesic medication at home

    After discharge, analgesic medication (type and amount) is tracked using a custom questionnaire.

    Measured: One month after injury

  22. Analgesic medication at home

    After discharge, analgesic medication (type and amount) is tracked using a custom questionnaire.

    Measured: Two months after injury

  23. Analgesic medication at home

    After discharge, analgesic medication (type and amount) is tracked using a custom questionnaire.

    Measured: Three months after injury

  24. Analgesic medication at home

    After discharge, analgesic medication (type and amount) is tracked using a custom questionnaire.

    Measured: Six months after injury

  25. Analgesic medication at home

    After discharge, analgesic medication (type and amount) is tracked using a custom questionnaire.

    Measured: Twelve months after injury

  26. Productivity & return to work

    The work productivity and activity impairment (WPAI) questionnaire is used. It assesses impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Score 0-10. 10 = high impairment

    Measured: One month after injury

  27. Productivity & return to work

    The work productivity and activity impairment (WPAI) questionnaire is used. It assesses impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Score 0-10. 10 = high impairment

    Measured: Two months after injury

  28. Productivity & return to work

    The work productivity and activity impairment (WPAI) questionnaire is used. It assesses impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Score 0-10. 10 = high impairment

    Measured: Three months after injury

  29. Productivity & return to work

    The work productivity and activity impairment (WPAI) questionnaire is used. It assesses impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Score 0-10. 10 = high impairment

    Measured: Six months after injury

  30. Productivity & return to work

    The work productivity and activity impairment (WPAI) questionnaire is used. It assesses impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Score 0-10. 10 = high impairment

    Measured: Twelve months after injury

  31. Pulmonary function

    Forced vital capacity (FVC, % predicted) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.

    Measured: Two months after injury

  32. Pulmonary function, forced vital capacity

    Forced vital capacity (FVC, % predicted) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.

    Measured: Six months after injury

  33. Pulmonary function, peak expiratory flow

    Peak expiratory flow (PEF, L/min) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.

    Measured: Two months after injury

  34. Pulmonary function, peak expiratory flow

    Peak expiratory flow (PEF, L/min) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.

    Measured: Six months after injury

  35. Pulmonary function, sniff nasal inspiratory pressure

    sniff nasal inspiratory pressure (in in cmH2O) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.

    Measured: Two months after injury

  36. Pulmonary function, sniff nasal inspiratory pressure

    sniff nasal inspiratory pressure (in in cmH2O) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.

    Measured: Six months after injury

  37. Pulmonary function, inspiratory pressure

    Maximum inspiratory pressure (in in cmH2O) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.

    Measured: Two months after injury

  38. Pulmonary function, inspiratory pressure

    Maximum inspiratory pressure (in in cmH2O) measured according to the recommendations of the European Respiratory Society. The best value of at least three tests is recorded.

    Measured: Six months after injury

  39. Length of hospital stay

    Length of hospital stay is reported in days from the day of hospitalization until the hospital discharge. The length of convalescence stay is also reported.

    Measured: from admission to discharge, up to four weeks

  40. Total costs

    Costs are reported at the end of the follow-up period (12 months) in swiss francs. They include costs for hospital treatment and costs for medication.

    Measured: Twelve months after injury

  41. Adverse events

    We collect safety outcomes in accordance with international standards (ISO 14155 and ICH-GCP)

    Measured: From inclusion to the end of the study, up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2021
  2. Study start12 Mar 2021
  3. Primary completion16 Nov 2023
  4. Study completion16 Sep 2024

Why it stopped: Participant recruitment was too low. One of the reasons is the overly strict exclusion criteria.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This pragmatic trial is a multi-center, two-arm, parallel-group, superiority randomized-controlled trial.
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04745520
Sponsor's protocol ID
2019-01688
Other IDs
2019
Acronym
PAROS
Status last verified
Jan 2025
First submitted
6 Dec 2020
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kerr-Valentic MA, Arthur M, Mullins RJ, Pearson TE, Mayberry JC. Rib fracture pain and disability: can we do better? J Trauma. 2003 Jun;54(6):1058-63; discussion 1063-4. doi: 10.1097/01.TA.0000060262.76267.EF.

    PubMed 12813323

  • Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013 May;205(5):511-5; discusssion 515-6. doi: 10.1016/j.amjsurg.2012.12.007.

    PubMed 23592156

  • Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31.

    PubMed 24612969

  • Marasco S, Lee G, Summerhayes R, Fitzgerald M, Bailey M. Quality of life after major trauma with multiple rib fractures. Injury. 2015 Jan;46(1):61-5. doi: 10.1016/j.injury.2014.06.014. Epub 2014 Jun 21.

    PubMed 25069400

  • Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.

    PubMed 8722735

  • de Moya M, Bramos T, Agarwal S, Fikry K, Janjua S, King DR, Alam HB, Velmahos GC, Burke P, Tobler W. Pain as an indication for rib fixation: a bi-institutional pilot study. J Trauma. 2011 Dec;71(6):1750-4. doi: 10.1097/TA.0b013e31823c85e9.

    PubMed 22182884

  • Wu WM, Yang Y, Gao ZL, Zhao TC, He WW. Which is better to multiple rib fractures, surgical treatment or conservative treatment? Int J Clin Exp Med. 2015 May 15;8(5):7930-6. eCollection 2015.

    PubMed 26221350

  • Fitzgerald MT, Ashley DW, Abukhdeir H, Christie DB 3rd. Rib fracture fixation in the 65 years and older population: A paradigm shift in management strategy at a Level I trauma center. J Trauma Acute Care Surg. 2017 Mar;82(3):524-527. doi: 10.1097/TA.0000000000001330.

    PubMed 28030506

  • Peek J, Smeeing DPJ, Hietbrink F, Houwert RM, Marsman M, de Jong MB. Comparison of analgesic interventions for traumatic rib fractures: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2019 Aug;45(4):597-622. doi: 10.1007/s00068-018-0918-7. Epub 2018 Feb 6.

    PubMed 29411048

  • Perentes JY, Christodoulou M, Abdelnour-Berchtold E, Karenovics W, Gayet-Ageron A, Gonzalez M, Krueger T, Triponez F, Terrier P, Bedat B. Effectiveness of rib fixation compared to pain medication alone on pain control in patients with uncomplicated rib fractures: study protocol of a pragmatic multicenter randomized controlled trial-the PAROS study (Pain After Rib OSteosynthesis). Trials. 2022 Sep 2;23(1):732. doi: 10.1186/s13063-022-06509-0.

    PubMed 36056421

Questions about this trial

What is this clinical trial studying?

A study testing Rib fixation and Analgesia in people with Rib Fractures, run by Benoît Bédat at 1 site in Switzerland.

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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. 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 stopped early (reason given: Participant recruitment was too low. One of the reasons is the overly strict exclusion criteria.). Results are not available in the source record.

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?

Pain severity (time frame: Two months after injury). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04745520, which also lists 10 linked publications.

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 20 Jan 2025.

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