IOA-Muticentric Research group: This research proposal is for IOA members only. If you want to participate in this proposal as mentioned below -please fill out the clinical record form of your patients, enter in an Excel sheet and send it to IOA or in the following email ortho_sujit@aiimsbhubaneswar.edu.in. We shall combine all data and publish in Indian Journal of Orthopaedics(IJO). You will be given authorship credit. Please remember that consent from the patients and institute for providing documents must be obtained. If needed, you can ask for Institutional ethics committee approval. There should not be any information about the patient's identity on the images or any other documents uploaded.
IOA Multicentric Research proposal
1. Title of the proposed research project: Osteonecrosis of hip among COVID survivors: An epidemiological study
2. Rationale (up to 350 words): The COVID-19 pandemic has affected the whole world in several phases. India is the worst hit by the second wave of the COVID-19 pandemic. The severity patterns were variable; mild cases were reported to be approximately 80%, severe cases were 14%, and critical cases were 6%. Although the involvement of lungs and internal organs were critical, musculoskeletal manifestations were common and disabling. Osteonecrosis of hip (ONFH) has been reported as a threatening complications among COVID survivors. There are many case series on ONFH among covid survivors. Prolonged steroid administration and COVID-induced coagulopathy leading to microthrombosis have been implicated in the pathogenesis of ONFH among COVID survivors. Early detection and treatment of ONFH are essential to reduce morbidity and prevent the development of arthritis. This study was designed to know the incidence of ONFH among COVID survivors in the Indian population and to know about their response to treatment.
3. Project Description:
Study setting: Muticentric studies from different centers/hospitals of India
Study design: Retrospective study
Aims and Objectives:
Primary objectives: To look for disease severity of ONFH among COVID survivors
Secondary objectives:
1. To look for the association of steroid intake (dose, duration) to the development of Osteonecrosis
2. To look for association of coagulation disorder to ONFH
3. To look for association of other risk factors (ICU stay/ antiviral treatment/ obesity/smoking/ severe cardiovascular or pulmonary disease) for subsequent development of ONFH
4. To look for reposne to joint salvage treatment (Core decompression, Core decompression with BMAC/ cultured osteoblast, vascularised/nonvascularised fibular graft etc)
5. Incidence of adavanced disease and need of THR
Study details: All COVID-19 survivors (both hospitals treated and under home care) who were diagnosed with ONFH will be included in this retrospective study. The inclusion criteria will be as follows:
1. Age >18 years
2. Must have been infected with COVID-19/ SARS COV 2
3. Must have been evaluated with adequate radiographs and MRI
Exclusion criteria:
1. Patients diagnosed with ONFH prior to COVID-19 pandemic (December 2019)
This retrospective study will evaluate the ONFH disease severity and treatment response among COVID survivors. Necessary institutional ethics committee approval and patient consent are needed for the study. The demographic profile (age, sex, BMI, vaccination status etc), history and ONFH disease severity details will be collected from the case records. The details of COVID symptoms, severity and treatment will also be collected from the history and records. The details will be entered into the proforma. The final data will be evaluated statistically to look for disease severity of ONFH among the COVID survivors.
References:
1. Sulewski A, Sieroń D, Szyluk K, Dąbrowski M, Kubaszewski Ł, Lukoszek D, Christe A. Avascular Necrosis Bone Complication after Active COVID-19 Infection: Preliminary Results. Medicina (Kaunas). 2021 Nov 30;57(12):1311. doi: 10.3390/medicina57121311. PMID: 34946256; PMCID: PMC8709043.
2. Agarwala SR, Vijayvargiya M, Pandey PAvascular necrosis as a part of ‘long COVID-19’BMJ Case Reports CP 2021;14:e242101.
3. Kachewar SG, Kachewar SS. MRI spectrum of avascular necrosis of femoral head in patients treated for COVID-19. Indian J Musculoskelet Radiol 2022;4:13-7.
Quesries can be asked to:
Dr Sujit Kumar Tripathy
Additional Professor, Orthopaedics
AIIMS Bhubaneswar
Ph: 9438884155
Email: ortho_sujit@aiimsbhubaneswar.edu.in
Age |
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Sex |
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BMI |
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Occupation |
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Address |
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Smoking (no of cigars/day, duration) |
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alcohol (dose per week, duration) |
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Comorbidties |
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Duration between COVID infection and onset of ONFH/AVN hip |
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unilateral (U)/bilateral (B) |
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Xray grading (FICAT and ARLET I, Iia, Iib, III, IV) |
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MRI grading (steinberg) |
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ARCO Grading |
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Hip pain (VAS) |
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Range of motion (Ab, Ad, Fl, Ex. Ir. Er) |
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mobility (independent. With stick or crtuches/wheelchair) |
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Deformity |
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Score if any-mHHS, WOMAC, HOOS) |
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COVID treatment at hospital (Hp) or home (Hm) |
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ICU/HDU or nonICU if hospitalised |
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Steroid name (if used) |
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Dose of steroid |
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Duration of steroid |
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Cumulative steroid dose |
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Blood coagualtion disorder present or not |
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on LMWH or not |
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Other medications received (antiviral/monoclonal ab/antiparasitic etc with dose duration) |
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Covid vaccine (doses, taken before ONFH or after, duration bwn vaccine and ONFH) |
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ONFH treatment (joint salvage-JS or THR) |
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what type of joint salvage |
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duration between diagnosis and surgical procedure |
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Bisphophonate dose, duration, if given |
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CD alone or with bone marrow aspiarate/ BMAC/ Stem cells cultured |
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fibular graft (vascular/nonvascular) |
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THR (cemented/uncemented) |
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Postop protocol (nonweight bearing/PWB/Full WB…duartion) |
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Follow up 3 months outcome (clinical, radiological-grade, VAS, Score if any-mHHS, WOMAC, HOOS) |
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Follow up 6 months outcome (clinical, radiological-grade, VAS, Score if any-mHHS, WOMAC, HOOS)) |
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Follow up 1 year outcome (clinical, radiological grade, VAS, Score if any-mHHS, WOMAC, HOOS)) |
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Follow up 2 years outcome (clinical, radiological grade, VAS, Score if any-mHHS, WOMAC, HOOS)) |
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Secondary surgery (THR or joint salvage) |
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Survivorship of primary surgery/ duration between primary joint salavage surgery and secondary surgery or THR |
Download Proforma Details in Excel Format