Orthopaedic DisordersNCT04516824
Experience of Orthopaedic and Spine Center Pakistan During COVID-19
An observational study of Orthopaedic Disorders, run by Ghurki Trust and Teaching Hospital at 1 site in Pakistan.
Trial summary
After the frightful outbreak in the city of Wuhan, China and its evidence of being contagious, governments around the world particularly United States in an effort to stop the transmission- imposed travel restrictions to and from China. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Orthopaedic Disorders
- What is being tested?
- Orthopaedic Surgical Procedures
- Type of treatment
- Surgery or procedure
- How many people
- 2,160 participants
- Where
- 1 sitePakistan
- Study dates
- 19 Mar 2020to 15 Aug 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient ≥ 18 years old in which urgent elective and emergency orthopaedic surgical procedures were needed during COVID-19 lock down period in Pakistan.
Who may be able to join
- Patients indicated for surgical procedure
- Less affording patients coming from remote areas with the need of immediate orthopaedic surgery
- Urgent elective and emergency procedures
Who cannot join
- Elective surgery cases which were not urgent
- Patients in whom conservative management could be considered.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experience of Workforce From Orthopaedic and Spine Center Ghurki Trust Hospital Pakistan During COVID-19
After the frightful outbreak in the city of Wuhan, China and its evidence of being contagious, governments around the world particularly United States in an effort to stop the transmission- imposed travel restrictions to and from China. Though it's a novel virus and little is known about it, the spread was drastic across the world. In fact the spread was so rapid that by end of February 2020, the number of new cases outside China had leveled up to 13 fold as compared to the number of cases in China. Moreover, the number of infected countries with COVID-19 tripled. The first two reported cases in Pakistan were from Karachi and Islamabad on 27 February 2020. These two cases presented with a recent travel history from Iran. The current statistics showed the confirmed cases in Pakistan reached upto 284,121 till 9 August 2020.
During the lockdown period most of the public hospitals and trust closed their Outpatient departments and started to deal with emergency cases only. However even in such situation there are some trust hospitals worth mentioning who never closed their services and worked day and night to entertain their patients by observing all the precautions and safety measures. Ghurki trust teaching hospital is one of them. This hospital adopted a SMART STRATEGY or SMART hospital lockdown.
Since 19th March 2020 till 13th July 2020, the period of lockdown, two thousand one hundred and sixty surgeries were performed by the orthopaedic team of Ghurki hospital. The breakup of surgeries during lockdown was as follows: 1514 cases of trauma, 173 procedures of spine, 51 for arthroplasty, 51 for arthroscopy, 21 for tumors and 350 miscellaneous. The team was available 24 hours, 7 days a week under the supervisor of Professor Amer Aziz, to play their part in these terrible circumstances.
Read the detailed description
After the frightful outbreak in the city of Wuhan, China and its evidence of being contagious, governments around the world particularly United States in an effort to stop the transmission- imposed travel restrictions to and from China. Though it's a novel virus and little is known about it, the spread was drastic across the world. In fact the spread was so rapid that by end of February 2020, the number of new cases outside China had levelled up to 13 fold as compared to the number of cases in China. Moreover, the number of infected countries with COVID-19 tripled. The first two reported cases in Pakistan were from Karachi and Islamabad on 27 February 2020. These two cases presented with a recent travel history from Iran. The current statistics showed the confirmed cases in Pakistan reached upto 284,121 till 9 August 2020.
Regarding the Pakistan's government response to COVID-19, quick steps were taken to curtail the transmission of virus as China is in northeast of Pakistan and also shares its borders with Iran where the number of cases are increasing exceptionally. As an initial response Pakistan closed its borders with China and implies strict methods at the Pakistan-Iran border. Still, in the initial days of pandemic Pakistan lacked the diagnosis kits and relied on China and Japan for testing purpose. However, later Pakistan was able to receive kits and started testing samples.
Pakistan's federal government along with the Ministry of Health (Moh) initiated a plan known as "National Action Plan for Corona Virus Disease Pakistan". The basic motive behind developing this plan was to generate policies and methods to combat with the deadly virus across Pakistan. MoH managed to deliver crucial supplies like masks, gloves and suits to the doctors and paramedical staffs working at frontlines. A state of confusion existed at different levels in health care system in Pakistan, particularly in Orthopaedic departments of hospital where elective and emergency services were severely affected during the lockdown period that started from 19 March 2020.
Orthopaedic and Spine Center Ghurki Trust Teaching Hospital Lahore:
During the lockdown period most of the public hospitals and trust closed their Outpatient departments and started to deal with emergency cases only. Even the private hospitals were reluctant to perform elective and emergency orthopaedic procedures. This attitude was may be due to the information published from other countries on the post operative complications and reduction of orthopaedic procedures during the period. The closure of orthopaedic health services brings a great shock to poor people for whom trusts and foundations is the last hope as they cannot afford the private setups for their health care facilities. However even in such situation there are some trust hospitals worth mentioning who never closed their services and worked day and night to entertain their patients by observing all the precautions and safety measures. Ghurki trust teaching hospital is one of them. This hospital adopted a SMART STRATEGY or SMART hospital lockdown. The orthopaedic department divided the members into five teams performing a 1:5 rotations. Each team comprised of one professor, one assistant professor, one senior registrar and ten trainee residents. Similarly the other departments like anesthesia, paramedics, nurses and physiotherapists were also subdivided. Out of two hundred staff, thirty were tested positive for COVID-19 but they all were managed and returned to normal after home quarantine.
Orthopaedic Surgeries during COVID-19:
Since 19th March 2020 till 13th July 2020, the period of lockdown, two thousand one hundred and sixty surgeries were performed by the orthopaedic team of Ghurki hospital. The breakup of surgeries during lockdown was as follows: 1514 cases of trauma, 173 procedures of spine, 51 for arthroplasty, 51 for arthroscopy, 21 for tumors and 350 miscellaneous. The team was available 24 hours, 7 days a week under the supervisor of Professor Amer Aziz, to play their part in these terrible circumstances. The team started their day with recitation of Quranic prayer which is translated as "In the name of Allah by whose name harm cannot be done by anything in the earth or in heavens. He is All-Hearing, All-Seeing" (Tirmidhi, Hadith: 3388). The smart approach utilized was that the patients were operated as soon as possible preferably within first twenty four hours and discharged them early also one to two days post op in most cases with complete education. All the patients were screened for COVID but Polymerase Chain Reaction test (PCR) and Pulmonary High-Resolution Computed Tomography (HRCT) was not done in all the patients unless if they presented with suspicious history. Fortunately, none of the patient tested positive pre operatively. Strict asepsis was observed during the period.
- Conditions
- Orthopaedic Disorders
- Being tested
- Orthopaedic Surgical Procedures
- Keywords
- COVID 19, Orthopaedic conditions, Orthopaedic Surgeries, Pakistan
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopaedic Surgical ProceduresProcedure or surgery
Intramedullary nails, Dynamic Compression Plate, Dynamic Hip Screw, Manipulation Under Anaesthesia POP, Ilizarov, Cannulated Screw Fixators, Bipolar Hemiarthroplasty, Locking Compression Plate, AO External fixators, Tension Band Wiring Patella, Pelvis and Acetabulum Fixations, Elbow Reconstructions, K wiring, Disc Excision, Spine Fracture i-e TPSF, Posterior Cervical Decompression and LMS, Dura repair, AD cage,Bilateral Total Hip Replacement, Unilateral Total Hip Replacement, Bilateral Total Knee Replacement, Unilateral Total Knee Replacement, Knee Arthroscopy for Mensicectomy, Arthroscopic Anterior Cruciate Ligament reconstruction,Removal of Implant, Amputations, VAC dressings,Wound wash, Arthrotomy for Septic Arthritis, Biopsy
| Study group | Role | What they receive |
|---|---|---|
| Trauma,Spine cases,Arthroplasty,Arthroscopy, Miscellaneous | Not described Receives: Procedure: Orthopaedic Surgical Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and functional characteristics
Describe the clinical and functional level of patients after surgery, hospitalized during lockdown period in our hospital
Measured: [Through study period, average 3 months]
Secondary outcomes (1)
Patient's journey
Describe patient's experience during the period of lockdown in our center
Measured: [Through study period, average 3 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start19 Mar 2020
- Primary completion13 Jul 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic DisordersStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ghurki Trust and Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Amer Aziz, Study director, Orthopaedic and Spine Center Ghurki Trust Hospital Lahore PakistanProf. Atiq Uz Zaman, Study chair, Orthopaedic and Spine Center Ghurki Trust Hospital Lahore PakistanProf Rizwan Akram, Study chair, Orthopaedic and Spine Center Ghurki Trust Hospital Lahore PakistanProf. Ijaz Ahmad, Study chair, Orthopaedic and Spine Center Ghurki Trust Hospital Lahore PakistanDr. Ashfaq Jadoon, Study chair, Orthopaedic and Spine Center Ghurki Trust Hospital Lahore PakistanDr. Majid Cheema, Study chair, Orthopaedic and Spine Center Ghurki Trust Hospital Lahore PakistanDr. Samreen Sadiq, Study chair, Lahore College of Physical Therapy LMDC GTTH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516824
- Sponsor's protocol ID
- 30
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- 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 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of Workforce From Orthopaedic and Spine Center Ghurki Trust Hospital Pakistan During COVID-19
- ClinicalTrials.gov ID
- NCT04516824
- Acronym / sponsor ID
- 30
- Conditions
- Orthopaedic Disorders
- Keywords
- COVID 19, Orthopaedic conditions, Orthopaedic Surgeries, Pakistan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,160 participants (actual)
- Lead sponsor
- Ghurki Trust and Teaching HospitalUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 18 Aug 2020 (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.
After the frightful outbreak in the city of Wuhan, China and its evidence of being contagious, governments around the world particularly United States in an effort to stop the transmission- imposed travel restrictions to and from China. Though it's a novel virus and little is known about it, the spread was drastic across the world. In fact the spread was so rapid that by end of February 2020, the number of new cases outside China had leveled up to 13 fold as compared to the number of cases in China. Moreover, the number of infected countries with COVID-19 tripled. The first two reported cases in Pakistan were from Karachi and Islamabad on 27 February 2020. These two cases presented with a recent travel history from Iran. The current statistics showed the confirmed cases in Pakistan reached upto 284,121 till 9 August 2020.
During the lockdown period most of the public hospitals and trust closed their Outpatient departments and started to deal with emergency cases only. However even in such situation there are some trust hospitals worth mentioning who never closed their services and worked day and night to entertain their patients by observing all the precautions and safety measures. Ghurki trust teaching hospital is one of them. This hospital adopted a SMART STRATEGY or SMART hospital lockdown.
Since 19th March 2020 till 13th July 2020, the period of lockdown, two thousand one hundred and sixty surgeries were performed by the orthopaedic team of Ghurki hospital. The breakup of surgeries during lockdown was as follows: 1514 cases of trauma, 173 procedures of spine, 51 for arthroplasty, 51 for arthroscopy, 21 for tumors and 350 miscellaneous. The team was available 24 hours, 7 days a week under the supervisor of Professor Amer Aziz, to play their part in these terrible circumstances.
Detailed description
After the frightful outbreak in the city of Wuhan, China and its evidence of being contagious, governments around the world particularly United States in an effort to stop the transmission- imposed travel restrictions to and from China. Though it's a novel virus and little is known about it, the spread was drastic across the world. In fact the spread was so rapid that by end of February 2020, the number of new cases outside China had levelled up to 13 fold as compared to the number of cases in China. Moreover, the number of infected countries with COVID-19 tripled. The first two reported cases in Pakistan were from Karachi and Islamabad on 27 February 2020. These two cases presented with a recent travel history from Iran. The current statistics showed the confirmed cases in Pakistan reached upto 284,121 till 9 August 2020.
Regarding the Pakistan's government response to COVID-19, quick steps were taken to curtail the transmission of virus as China is in northeast of Pakistan and also shares its borders with Iran where the number of cases are increasing exceptionally. As an initial response Pakistan closed its borders with China and implies strict methods at the Pakistan-Iran border. Still, in the initial days of pandemic Pakistan lacked the diagnosis kits and relied on China and Japan for testing purpose. However, later Pakistan was able to receive kits and started testing samples.
Pakistan's federal government along with the Ministry of Health (Moh) initiated a plan known as "National Action Plan for Corona Virus Disease Pakistan". The basic motive behind developing this plan was to generate policies and methods to combat with the deadly virus across Pakistan. MoH managed to deliver crucial supplies like masks, gloves and suits to the doctors and paramedical staffs working at frontlines. A state of confusion existed at different levels in health care system in Pakistan, particularly in Orthopaedic departments of hospital where elective and emergency services were severely affected during the lockdown period that started from 19 March 2020.
Orthopaedic and Spine Center Ghurki Trust Teaching Hospital Lahore:
During the lockdown period most of the public hospitals and trust closed their Outpatient departments and started to deal with emergency cases only. Even the private hospitals were reluctant to perform elective and emergency orthopaedic procedures. This attitude was may be due to the information published from other countries on the post operative complications and reduction of orthopaedic procedures during the period. The closure of orthopaedic health services brings a great shock to poor people for whom trusts and foundations is the last hope as they cannot afford the private setups for their health care facilities. However even in such situation there are some trust hospitals worth mentioning who never closed their services and worked day and night to entertain their patients by observing all the precautions and safety measures. Ghurki trust teaching hospital is one of them. This hospital adopted a SMART STRATEGY or SMART hospital lockdown. The orthopaedic department divided the members into five teams performing a 1:5 rotations. Each team comprised of one professor, one assistant professor, one senior registrar and ten trainee residents. Similarly the other departments like anesthesia, paramedics, nurses and physiotherapists were also subdivided. Out of two hundred staff, thirty were tested positive for COVID-19 but they all were managed and returned to normal after home quarantine.
Orthopaedic Surgeries during COVID-19:
Since 19th March 2020 till 13th July 2020, the period of lockdown, two thousand one hundred and sixty surgeries were performed by the orthopaedic team of Ghurki hospital. The breakup of surgeries during lockdown was as follows: 1514 cases of trauma, 173 procedures of spine, 51 for arthroplasty, 51 for arthroscopy, 21 for tumors and 350 miscellaneous. The team was available 24 hours, 7 days a week under the supervisor of Professor Amer Aziz, to play their part in these terrible circumstances. The team started their day with recitation of Quranic prayer which is translated as "In the name of Allah by whose name harm cannot be done by anything in the earth or in heavens. He is All-Hearing, All-Seeing" (Tirmidhi, Hadith: 3388). The smart approach utilized was that the patients were operated as soon as possible preferably within first twenty four hours and discharged them early also one to two days post op in most cases with complete education. All the patients were screened for COVID but Polymerase Chain Reaction test (PCR) and Pulmonary High-Resolution Computed Tomography (HRCT) was not done in all the patients unless if they presented with suspicious history. Fortunately, none of the patient tested positive pre operatively. Strict asepsis was observed during the period.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trauma,Spine cases,Arthroplasty,Arthroscopy, Miscellaneous | – | Procedure: Orthopaedic Surgical Procedures |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient ≥ 18 years old in which urgent elective and emergency orthopaedic surgical procedures were needed during COVID-19 lock down period in Pakistan.
Key inclusion criteria (3 listed)
- Patients indicated for surgical procedure
- Less affording patients coming from remote areas with the need of immediate orthopaedic surgery
- Urgent elective and emergency procedures
Key exclusion criteria (2 listed)
- Elective surgery cases which were not urgent
- Patients in whom conservative management could be considered.
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 |
|---|---|---|
| Orthopaedic Surgical ProceduresIntramedullary nails, Dynamic Compression Plate, Dynamic Hip Screw, Manipulation Under Anaesthesia POP, Ilizarov, Cannulated Screw Fixators, Bipolar Hemiarthroplasty, Locking Compression Plate, AO External fixators, Tension Band Wiring Patella, Pelvis and Acetabulum Fixations, Elbow Reconstructions, K wiring, Disc Excision, Spine Fracture i-e TPSF, Posterior Cervical Decompression and LMS, Dura repair, AD cage,Bilateral Total Hip Replacement, Unilateral Total Hip Replacement, Bilateral Total Knee Replacement, Unilateral Total Knee Replacement, Knee Arthroscopy for Mensicectomy, Arthroscopic Anterior Cruciate Ligament reconstruction,Removal of Implant, Amputations, VAC dressings,Wound wash, Arthrotomy for Septic Arthritis, Biopsy | Procedure or surgery | Trauma,Spine cases,Arthroplasty,Arthroscopy, Miscellaneous |
Primary outcome
Clinical and functional characteristics
Time frame: [Through study period, average 3 months]
Describe the clinical and functional level of patients after surgery, hospitalized during lockdown period in our hospital
1 secondary outcome
Patient's journey
Time frame: [Through study period, average 3 months]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- 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.
Prof Amer Aziz study director
Orthopaedic and Spine Center Ghurki Trust Hospital Lahore Pakistan
Prof. Atiq Uz Zaman study chair
Orthopaedic and Spine Center Ghurki Trust Hospital Lahore Pakistan
Prof Rizwan Akram study chair
Orthopaedic and Spine Center Ghurki Trust Hospital Lahore Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopaedic Disorders, run by Ghurki Trust and Teaching Hospital at 1 site in Pakistan.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Aug 2020. 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 Pakistan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical and functional characteristics (time frame: [Through study period, average 3 months]). 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 18 Aug 2020.