NCT04516824

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,160

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 19, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

August 16, 2020

Last Update Submit

August 16, 2020

Conditions

Keywords

COVID 19Orthopaedic conditionsOrthopaedic SurgeriesPakistan

Outcome Measures

Primary Outcomes (1)

  • Clinical and functional characteristics

    Describe the clinical and functional level of patients after surgery, hospitalized during lockdown period in our hospital

    [Through study period, average 3 months]

Secondary Outcomes (1)

  • Patient's journey

    [Through study period, average 3 months]

Study Arms (1)

Trauma,Spine cases,Arthroplasty,Arthroscopy, Miscellaneous

Procedure: Orthopaedic Surgical Procedures

Interventions

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

Trauma,Spine cases,Arthroplasty,Arthroscopy, Miscellaneous

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patients indicated for surgical procedure
  • Less affording patients coming from remote areas with the need of immediate orthopaedic surgery
  • Urgent elective and emergency procedures

You may not qualify if:

  • Elective surgery cases which were not urgent
  • Patients in whom conservative management could be considered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki trust hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Prof Amer Aziz

    Orthopaedic and Spine Center Ghurki Trust Hospital Lahore Pakistan

    STUDY DIRECTOR
  • Prof. Atiq Uz Zaman

    Orthopaedic and Spine Center Ghurki Trust Hospital Lahore Pakistan

    STUDY CHAIR
  • Prof Rizwan Akram

    Orthopaedic and Spine Center Ghurki Trust Hospital Lahore Pakistan

    STUDY CHAIR
  • Prof. Ijaz Ahmad

    Orthopaedic and Spine Center Ghurki Trust Hospital Lahore Pakistan

    STUDY CHAIR
  • Dr. Ashfaq Jadoon

    Orthopaedic and Spine Center Ghurki Trust Hospital Lahore Pakistan

    STUDY CHAIR
  • Dr. Majid Cheema

    Orthopaedic and Spine Center Ghurki Trust Hospital Lahore Pakistan

    STUDY CHAIR
  • Dr. Samreen Sadiq

    Lahore College of Physical Therapy LMDC GTTH

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2020

First Posted

August 18, 2020

Study Start

March 19, 2020

Primary Completion

July 13, 2020

Study Completion

August 15, 2020

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations