Hip FracturesNCT03822247
Evaluation of Multidisciplinary Recovery After Surgery Program in Orthopedics and Traumatology
A study testing Multidisciplinary Recovery Program in people with Hip Fractures and Knee Fracture, run by Klinički Bolnički Centar Zagreb at 1 site in Croatia.
Trial summary
The aim of the recovery protocol is to reduce surgical trauma, postoperative pain, and complications, shorten hospital treatment and improve postoperative recovery. Orthopedic and traumatology surgeries are often followed by a long-lasting recovery with difficulties of everyday functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Knee Fracture, Hip Arthritis
- What is being tested?
- Multidisciplinary Recovery Program
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Dec 2018to 1 Jan 2020
- 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
- Fracture od proximal femur or knee fracture requiring surgery
- Hip or knee arthrosis requiring joint replacement
- American Society of Anesthesiologists (ASA) score II or III
- Ability to provide informed consent
Who cannot join
- Severe cognitive impairment
- Pregnancy
- End stage of malignant disease
- Decompensated heart or liver disease
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
KBC Zagreb
Zagreb, 10000
Nikica Daraboš, +385 1 2388 203, nikica.darabos@kbc-zagreb.hr
About this study
Official title: A Prospective, Randomized Comparison of Multidisciplinary Recovery After Surgery Program and Conventional Protocol for Perioperative Care in Orthopedics and Traumatology
The aim of the recovery protocol is to reduce surgical trauma, postoperative pain, and complications, shorten hospital treatment and improve postoperative recovery. Orthopedic and traumatology surgeries are often followed by a long-lasting recovery with difficulties of everyday functioning. Up to this time, only a few publications of multidisciplinary protocol in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of multidisciplinary after surgery recovery program in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It focuses on patient education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The implementation of the program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.
Read the detailed description
The protocol combines scientifically proven interventions to standardize medical care, improve treatment outcomes and reduce healthcare costs. The aim is to reduce surgical trauma and postoperative pain, reduce complications, shorten hospital treatment and improve postoperative recovery. Moreover, it has been shown that using standardized, patient oriented recovery protocol significantly improves the outcomes and quality of care, but also brings financial benefit for the hospital as well as for the health system in general. Studies about implementing multidisciplinary recovery protocol in orthopedic and traumatology are scarce. Orthopedic and traumatology surgeries are often followed by a long-lasting and demanding recovery characterized by the difficulties of everyday functioning. Recovery is therefore multidisciplinary: for example, it is necessary to monitor the nutritional status of a patient, decrease postoperative pain, monitor cognitive status, etc. Until now only a few publications of recovery protocols in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of this protocol in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It was created based on evidence-based practice and modified by multidisciplinary team of orthopedic and traumatology surgeons, anesthesiologists, physiatrist, physiotherapists, specialized medical nurses, nutritionists, and psychiatrists. It focuses on patient preoperative education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified local and regional anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The investigators postulate that the implementation of this program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.
- Conditions
- Hip Fractures, Knee Fracture, Hip Arthritis, Knee Arthritis
- Being tested
- Multidisciplinary Recovery Program
- Keywords
- Recovery, Patient reported outcome measures, Hip fracture, Hip arthritis, Knee fracture, Knee arthritis
- Medical subject headings
- Hip Fractures, Knee Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Recovery ProgramProcedure or surgery
Preoperative care:
- Patient's education
- Providing respiratory training
- Assessment of nutritional status
- Application of compression stockings
- Thromboembolism prophylaxis by low molecular weighted heparin
- Induction of hemodynamic support 12 hours before the surgery
- Oral carbohydrate solution loading until 2 hours before the surgery
Intraoperative care:
- Maintaining normothermia
- Multimodal prevention of postoperative nausea and vomiting
- Use of spinal anesthesia
- Prevention of excessive blood loss
- Local anesthetic infiltration
Postoperative care:
- Active pain control
- Early mobilization
- Early onset of oral nutrition
- Early delirium detection
- Application of compression stockings
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary Recovery Program | Experimental | Two cohorts of patients will randomly be placed in either experimental od no intervention group.
Patients undergoing Multidisciplinary Recovery After Surgery Program will gain better preparation for early mobilization after surgery, nutritional support, individually modified analgesia and psychological support during inpatient treatment. Program includes preoperative, intraoperative and postoperative multidisciplinary comprehensive interventions. Receives: Procedure: Multidisciplinary Recovery Program |
| Conventional Perioperative Care | No intervention | Patients undergoing conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Postoperative Complications
Occurrence of early complications:
- Dislocation or malpositioning of joint replacement
- Neurological deficit
- Need for blood transfusion
- Postoperative delirium
- Nausea or vomiting
- Pneumonia
- Headache
- Wound dehiscence, secretion, inflammation, bleeding
Measured: 48 hours after surgery
Late Postoperative Complications
Occurrence of late complications:
- Wound infection, healing by secundam
- Decubitus
- Fracture of joint replacement
- Aseptic loosening of hip joint replacement
- Infection of joint replacement
- Thromboembolism
- Need for a revision
Measured: 10 days after surgery
Secondary outcomes (5)
Readmission rates
Rate of readmission to the hospital
Measured: 30 days after surgery
Patient-reported outcome after orthopedic surgery using The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into 3 subscales (pain, stiffness and physical function). The questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score; higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: 2 days, 60 days after surgery, 90 days after surgery
Pain assessment using Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a unidimensional measure of pain intensity. It is a straight horizontal line of fixed length of 100 mm. The ends are defined as the extreme limits of pain orientated from the left (worst) to the right (best). The score represents the distance measured (mm) between the worst and best mark, providing a range of scores between 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: 1 day, 2 days, 60 days after surgery, 90 days after surgery
Assessment of health related quality of life using Euro Quality of Life Index (Euro QoL 5-D 5-L)
The instrument Euro Quality of Life Index (Euro QoL 5-D 5-L) measures five dimensions, Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression. Each dimension can be rated at five levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 55555 indicating major problems in any of the five health dimensions. Second part of the instrument is the Visual Analogue Scale to assess health status at baseline, where 0 signifies worst imaginable health state, and 100 signifies best imaginable health state.
Measured: baseline, 2 days, 60 days after surgery, 90 days after surgery
Evaluation of patients' satisfaction with the care provided using The Short-form patient satisfaction questionnaire (PSQ-18)
The Short-form patient satisfaction questionnaire (PSQ-18) contains 18 items tapping each of the seven dimension of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with the doctor and accessibility and convenience. All items are scored so that high scores reflect satisfaction with medical care and after item scoring, items within the same subscale should be averaged together to create the seven subscale scores.
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Dec 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinički Bolnički Centar Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikica Darabos, Klinički Bolnički Centar Zagreb
- Investigators
- Nikica Daraboš, Study chair, Head of Department of traumatology, bone and joint surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822247
- Sponsor's protocol ID
- KBC Zagreb Surgery
- Status last verified
- Feb 2019
- First submitted
- 27 Jan 2019
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Comparison of Multidisciplinary Recovery After Surgery Program and Conventional Protocol for Perioperative Care in Orthopedics and Traumatology
- ClinicalTrials.gov ID
- NCT03822247
- Acronym / sponsor ID
- KBC Zagreb Surgery
- Conditions
- Hip Fractures, Knee Fracture, Hip Arthritis, Knee Arthritis
- Keywords
- Recovery, Patient reported outcome measures, Hip fracture, Hip arthritis, Knee fracture, Knee arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Klinički Bolnički Centar ZagrebUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 30 Jan 2019 (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 aim of the recovery protocol is to reduce surgical trauma, postoperative pain, and complications, shorten hospital treatment and improve postoperative recovery. Orthopedic and traumatology surgeries are often followed by a long-lasting recovery with difficulties of everyday functioning. Up to this time, only a few publications of multidisciplinary protocol in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of multidisciplinary after surgery recovery program in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It focuses on patient education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The implementation of the program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.
Detailed description
The protocol combines scientifically proven interventions to standardize medical care, improve treatment outcomes and reduce healthcare costs. The aim is to reduce surgical trauma and postoperative pain, reduce complications, shorten hospital treatment and improve postoperative recovery. Moreover, it has been shown that using standardized, patient oriented recovery protocol significantly improves the outcomes and quality of care, but also brings financial benefit for the hospital as well as for the health system in general. Studies about implementing multidisciplinary recovery protocol in orthopedic and traumatology are scarce. Orthopedic and traumatology surgeries are often followed by a long-lasting and demanding recovery characterized by the difficulties of everyday functioning. Recovery is therefore multidisciplinary: for example, it is necessary to monitor the nutritional status of a patient, decrease postoperative pain, monitor cognitive status, etc. Until now only a few publications of recovery protocols in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of this protocol in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It was created based on evidence-based practice and modified by multidisciplinary team of orthopedic and traumatology surgeons, anesthesiologists, physiatrist, physiotherapists, specialized medical nurses, nutritionists, and psychiatrists. It focuses on patient preoperative education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified local and regional anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The investigators postulate that the implementation of this program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary Recovery Program | Experimental | Procedure: Multidisciplinary Recovery ProgramTwo cohorts of patients will randomly be placed in either experimental od no intervention group. Patients undergoing Multidisciplinary Recovery After Surgery Program will gain better preparation for early mobilization after surgery, nutritional support, individually modified analgesia and psychological support during inpatient treatment. Program includes preoperative, intraoperative and postoperative multidisciplinary comprehensive interventions. |
| Conventional Perioperative Care | No intervention | –Patients undergoing conventional care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fracture od proximal femur or knee fracture requiring surgery
- Hip or knee arthrosis requiring joint replacement
- American Society of Anesthesiologists (ASA) score II or III
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Severe cognitive impairment
- Pregnancy
- End stage of malignant disease
- Decompensated heart or liver disease
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 |
|---|---|---|
| Multidisciplinary Recovery ProgramPreoperative care: * Patient's education * Providing respiratory training * Assessment of nutritional status * Application of compression stockings * Thromboembolism prophylaxis by low molecular weighted heparin * Induction of hemodynamic support 12 hours before the surgery * Oral carbohydrate solution loading until 2 hours before the surgery Intraoperative care: * Maintaining normothermia * Multimodal prevention of postoperative nausea and vomiting * Use of spinal anesthesia * Prevention of excessive blood loss * Local anesthetic infiltration Postoperative care: * Active pain control * Early mobilization * Early onset of oral nutrition * Early delirium detection * Application of compression stockings | Procedure or surgery | Multidisciplinary Recovery Program |
Primary outcome
Early Postoperative Complications
Time frame: 48 hours after surgery
Occurrence of early complications: * Dislocation or malpositioning of joint replacement * Neurological deficit * Need for blood transfusion * Postoperative delirium * Nausea or vomiting * Pneumonia * Headache * Wound dehiscence, secretion, inflammation, bleeding
Late Postoperative Complications
Time frame: 10 days after surgery
Occurrence of late complications: * Wound infection, healing by secundam * Decubitus * Fracture of joint replacement * Aseptic loosening of hip joint replacement * Infection of joint replacement * Thromboembolism * Need for a revision
5 secondary outcomes
Readmission rates
Time frame: 30 days after surgery
Patient-reported outcome after orthopedic surgery using The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 2 days, 60 days after surgery, 90 days after surgery
Pain assessment using Visual Analog Scale (VAS)
Time frame: 1 day, 2 days, 60 days after surgery, 90 days after surgery
Assessment of health related quality of life using Euro Quality of Life Index (Euro QoL 5-D 5-L)
Time frame: baseline, 2 days, 60 days after surgery, 90 days after surgery
Evaluation of patients' satisfaction with the care provided using The Short-form patient satisfaction questionnaire (PSQ-18)
Time frame: 3 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Nikica Daraboš study chair
Head of Department of traumatology, bone and joint surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Recovery Program in people with Hip Fractures and Knee Fracture, run by Klinički Bolnički Centar Zagreb at 1 site in Croatia.
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 4 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 19 Feb 2019. 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 Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikica Daraboš (+385 1 2388 203, nikica.darabos@kbc-zagreb.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Postoperative Complications (time frame: 48 hours after surgery). The study lists 2 primary outcomes in all. 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 19 Feb 2019.