WIXLIB

Section IIIntroduction to RegistriesA registry is an important research tool for any clinician.Registries can help practice in a number of ways.Following are some FAQ’s that help describe whatregistries are.list of individuals (registry coordinator) who may haveaccess to participants’ personal, identifying information.; Those individuals must be specially trained and certifiedregarding information security requirements.Why are registries needed?Who owns the data from a registry? Whomakes decisions about how these data willbe used?Registries can provide health care professionals andresearchers with first-hand information about peoplewith certain conditions, both individually and as a group,and over time, to increase our understanding of thatcondition. Some registries collect information that canbe used to track trends about the number of people withdiseases, treatments, and more. Other registries invitepeople to sign up to be contacted about participatingin clinical research. These ask very basic questions abouthealth history that would help determine whethersomeone is possibly eligible to join a research study.It sounds like these registries collect personal healthinformation. Is there a risk that such information couldbe disclosed?Government agencies have strict privacy requirementsset by law such as the Federal Information SecurityManagement Act (FISMA), and the Health InsurancePortability and Accountability Act (HIPAA). If registrieshave followed all of these rules, the likelihood ofidentifiable personal information being shared is verysmall.What benefits will someone receive fromparticipating in a registry?Participation in a registry is likely to increase whatwe know about a specific condition, help health careprofessionals improve treatment, and allow researchersto design better studies on a particular condition,including development and testing of new treatments.Being part of a clinical trials registry can help peopleinterested in participating in research connect withclinical investigators? However, individuals (and theirfamilies) who choose to participate in a registry shouldunderstand that participation will not guarantee atreatment or cure for their condition or that they will beeligible to join a study.The data collected in a disease registry is stripped ofpersonal information. It belongs to the sponsor of theregistry, and depending on how the registry is set up,may be shared with the participants and their families,and approved health care professionals and researchers.However, personal, identifying information is keptprivate. Usually, a registry has a governing committeethat makes decisions about how the data can be usedor shared.Can a participant withdraw from theregistry?Yes. Registries are free and voluntary; there is no penaltyfor choosing to withdraw at any point.Who should the participant contact withadditional questions or concerns?For any questions about participation or any issuesthat may arise, registries provide a contact, usually theregistry coordinator.How is a registry different from a clinicaltrial?Registries focused on specific diseases or conditionscollect information voluntarily from people with thoseconditions. Clinical trials registries collect basic healthinformation from people who agree to be contactedabout participating in future clinical trials or studies. Aclinical trial is the study of new ways to prevent, detector treat diseases or conditions. Volunteering for a registrydoes not mean a person has signed up for a clinicaltrial. Participation in a disease registry can sometimesbecome a first step toward participation in a clinical trial,but registries and specific trials are not directly linked.Who has access to the information in aregistry?Usually, a federally-funded registry has a very limited2 Introduction to Registries11

Introduction to RegistriesWhat are the standards for Data Registries1. Develop a formal study protocol2. Measure outcomes that people in the population ofinterest notice and care about3. Describe data linkage plans, if applicable4. Plan follow-up based on registry objective(s)5. Describe data safety and security6. Take appropriate steps to ensure data quality7. Document and explain any modifications to theprotocol8. Collect data consistently9. Enroll and follow patients systematically10. Monitor and take actions to keep loss to follow-upto an acceptable minimum11. Use appropriate statistical techniques to addressconfounding.What are the types of national registries?1. Patient organization registries2. Medical registries3. Health Ministry registries4. Mixed systemsWhat are the steps in establishing anational patient registry?Step 1: Organize a registry committeeStep 2: Establish goals of the registryStep 3: Prepare your action planStep 4: Select the system of data collectionStep 5: Determine the data contentStep 6: Design the data collection formStep 7: Collect the dataStep 8: Analyze the dataStep 9: Review the registry systemMaintaining and using a national registry12Introduction to Registries2

Section III

Section IIIPNJR Steering CommitteeProfessor Syed Shahid NoorDirector & Coordinating PI, PNJREmail:ssnoor@yahoo.comProfessor Muhammad Amin ChinoyNational Coordinator PNJREmail:chinoy786@gmail.comProfessor Anisuddin BhattiNational Coordinator POAEmail:dranisbhatti@gmail.comProfessor Major General Suhail HafeezRegional Coordinator PNJR (Punjab)Email: colsohail@hotmail.comProfessor Muhammed Arif KhanRegional Coordinator PNJR (KPK)Email: a khan37@yahoo.co.ukProfessor Mansoor Ali KhanRegional Coordinator PNJR (Sindh)Email: makbonedoc65@gmail.comDr Saleh TareenRegional Coordinator PNJR (Baluchistan)Email: drsaleh tareen@yahoo.comResearch PartnerMetrics Research3PNJR Steering Committee15

Section IV

Section IVPNJR Regional Coordinator NetworkDirector CoordinatorResearch Coordinator SouthSyed Munawar Ali,Tariq Mubarik,Metrics ResearchMetrics ResearchLead MonitorResearch Coordinator NorthDr Sadia Altaf,Dr. Muhammad Asif Mahmood,Metrics ResearchMetrics ResearchSupporting TeamDr Kamlesh PermanandMr Ali Hyder Qureshi4 PNJR Regional Coordinator Network19

Section V

30Introduction to PAS and PNJR1

Section VPNJR Stakeholders NetworkPakistan National Joint Registry could not have beenformed without the commitments of its valuable stakeholders. Each stake holder support and cooperation hasenabled us to achieve our 1st year targets. There arenumber of stake holders but the following few are mostsignificant:I. Pakistan Arthroplasty SocietyThe board and members of Pakistan ArthroplastySociety take full ownership of PNJR project andhave extended their extensive human and financialresources for the realization of this project. Allfinancial funding for PNJR is exclusively supportedby PAS.from data management, data tracking, data backupand cleaning to complete audit trails, reports/graphgeneration, dataset building for SAS/SPSS analysis. Theyalso help in resolving technical site issues and providetraining and support to maintain “Data Quality”.IV. Affiliated Institutions / Clinical SitesInstitutes are the back bone of any clinical researchactivity. All our registered hospitals are supporting us inproviding: access to patient data, logistics for data entry,utilities and use of their valuable and reputable name.SINDH1.Abbasi Shaheed Hospital, Karachi.2.Darul Sehat Hospital, Karachi3.Dow International Medical College, DUHS,Karachi.4.Institute of Orthopaedic & Surgery Pvt. Ltd.5.Jinnah Postgraduate Medical Center, Karachi.6.KPT Hospital, Karachi.7.Liaquat National Hospital, Karachi.8.MediCare Cardiac and General Hospital,Karachi.9.National Medical Center, Karachi.10.NMI Hospital, Karachi.11.Orthopaedic & Medical Institute, Karachi12.Patel Hospital, Karachi13.Royal Institute of Medical Sciences, Karachi.14.South City Hospital, Pvt. Ltd, Karachi.15.Seven day Hospital, Karachi.16.The Aga Khan University and Hospital, Karachi.17.The Indus Hospital, Karachi.Collage Solutions18.TO Clinic, Karachi.Collage Solutions with an extensive knowledge andexperience in data management, EDC, eCRF, CTMSdesign and development provided the expertise todevelop PNJR registry database. These provide services19.Ziauddin University and Hospital, Clifton,Karachi.II. PatientsPatients are at the center of all we do. Without thecontribution of our patients, we would not haveachieved this 1st annual report. We believe thattheir contribution will take us to newer heights inscientific research to benefit the masses in general.PNJR steering committee extends their thanks toall those patients who have contributed to this firstannual report.III. Research/Registry development partnersMetrics Research Pvt. LtdMetrics Research took this project as a challenge anddevotedly provided its services in designing of protocol,CRF, ICF, data entry and data analysis. The experiencedtrained team members assisted PNJR in every step ofdevelopment and publication.5PNJR Stakeholders Network23

PNJR Stakeholders NetworkPUNJABSINDH20.Aman Hospital, Civil quarters, Lahore.1.Prof. Anisuddin Bhatti21.Allama Iqbal Medical College/Jinnah Hospital.2.Prof. Asif Qureshi22.Benazir Bhutto Hospital, Islamabad.3.Dr. Aslam Pervez23.Combine Military Hospital, Rawalpindi4.Dr. Intikhab Taufeeq24.Combine Military Hospital, Lahore.5.Dr. Idrees Shah25.Doctors Hospital, Johar Town, Lahore.6.Dr. Imtiaz Ahmed Hashmi26.Family Hospital, Lahore.7.Dr. Iqbal Malik27.Ghurki Trust Teaching Hospital, Lahore.8.Prof. Kamran Ahmad28.King Edward Medical University, MayoHospital, Lahore.9.Prof. Mansoor Ali Khan10.Prof. Dr. Maratb Ali29.Lahore General Hospital, Lahore.11.Dr. Masood Umer30.Mid City Hospital, Jail Road, Lahore.12.Prof. Muhammad Amin Chinoy31.National Hospital, Defence, Lahore.13.Prof. Muhammad Umar32.Quaid-e-Azam International Hospital,Islamabad.14.Dr. Nasir Ahmad33.SIMS/ Services Hospital, Lahore.15.Prof. Pervez Anjum34.Sheikh Zayed Hospital, Lahore.16.Dr. Riaz Hussain Lakdawala35.Sir Ganga Ram Hospital, Queen’s Road, Lahore.17.Dr. S. Sajid hussain36.Surgimed Hospital, Lahore.18.Dr. Sohail Rafi19.Prof. Syed Shahid Noor20.Dr. Zaki IdreesKHYBER PAKHTUNKHWAH37.Hayatabad Medical Complex, Peshawar.38.Khyber Teaching Hospital, Peshawar.39.North West General Hospital, Hayatabad,Peshawar.BALUCHISTAN40.Bolan Medical Complex hospital41.Doctors hospital ,Quetta42.Saleem Complex HospitalV.Principal InvestigatorsSurgeons who strive hard to enter the data and keepthe registry ticking are what keeps this registry alive.Following is the list of our registered investigators.24PNJR Stakeholders Network5PUNJAB20.Dr. Abdullah Shah21.Prof. Abu Bakar Siddiq22.Prof. Amer Aziz23.Dr. Ijaz Ahmad24.Dr. Muhammad Akhtar Malik25.Prof. Ali Raza Hashmi26.Dr. Atiq-uz-Zaman27.Dr. Faisal Masood28.Prof. Ghazanfar Ali Shah29.Prof. Irfan Mehboob30.Dr. Khalid Saleem Aslam31.Dr. Mian Muhammad Hanif

PNJR Stakeholders Network32.Prof. Naeem Ahmed33.Prof. Rana Dilawaiz Nadeem34.Dr. Rana M. Arshad35.Dr. Rizwan Akram36.Prof. Shafique Ahmed Shafaq37.Dr. Shahzad Javed38.Prof. Maj. General Sohail Hafeez39.Prof. Col. Suhail Amin40.Dr. Tahseen Riaz41.Prof. Yawar AnisKHYBER PAKHTUNKHWA42.Dr. Awal Hakeem43.Dr. Israr Ahmad44.Dr. Khushnood Ali Baz45.Prof. M. Arif Khan46.Dr. Malik Javed Iqbal47.Prof. Muhammad Salim48.Dr. Obaid-ur-Rehman49.Prof. Raja Irfan Qadir50.Dr. Syed Imran Bukhari51.Prof. Zahid AskarBALUCHISTAN52.Dr. Amanullah Kakar53.Dr. Khawand Bakhsh Umbrani54.Dr. Saleh TareenVI.List of partner implant suppliers1. Zimmer, Inc.2. DePuy, Johnson and Johnson.3. United Orthopadics.4. Surgival5. Biomet6. Irene7. Miscellaneous5 PNJR Stakeholders Network25

Section VI

Section VIRegistry development and data collection toolsThis section will introduce key features of data recordingsystem that consist of case report form (CRF) for bothprimary and revision hip and knee arthroplasty inmanual and electronic version (eCRF).It was a great challenge to develop a comprehensivedata recording system, covering all the required fieldsto benefit the patient and the principal investigator.The clinical research forms and data recording systemsof all the existing international registries were obtainedand analyzed in detail in a meeting of the steeringcommittee of Pakistan Arthroplasty Society (PAS)held at Liaquat National Hospital and Medical College(LNH&MC), Karachi on 2nd of December, 2013 and abasic structure of Case Report Form (CRF) of PakistanNational Joint Registry was designed. This basic CRF wasthen assessed by the National and international facultyof PAS and they were requested for comments andsuggestions for further improvement. This trial versionof CRF was then made available for the members tocheck that how efficiently information can be obtained.In a second meeting of the steering committee ofPAS, the suggestions by the national, internationalfaculty and members were discussed and necessarymodifications were made in the CRF to make it final.A detailed informed consent form (ICF) was designedand translated in both Urdu and English for betterunderstanding of the patient in obtaining informedconsent. Collecting the data to improve patient care iscertainly a noble goal. But we know that anything thatcan be used for good purposes can also be used in waysthat may cause harm. Whenever data is collected, itis important to consider whether the project is askinguseful and appropriate study questions, whether theinformation being gathered will be useful in answeringthe study questions, and whether more information, lessinformation, or other information should be gathered. Itis also important to consider whether the data is beinganalyzed by an informed, competent, and unbiasedteam. For that the research protocols, informed consentform and CRF were all submitted to institutional reviewboard (IRB) at Indus Hospital Karachi for approval andIRB approval for the PNJR was obtained.The PNJR was launched at an inauguration ceremonyheld in Karachi on 15th of February, 2014 at Collegeof Physicians and Surgeons, Karachi with live telecastwith all CPSP centers in Pakistan. All the principalinvestigators were invited in that ceremony and hardcopies of PNJR-CRF were distributed among them. In thesame session they were trained to use the online versionof PNJR. Online accounts of all principal investigatorswere made for the easy and quick access to their owndata by specific login and password after signing a MoUbetween principle investigator and PAS.The offline version and smart phone application of PNJRis under process and will be available soon.Different components of CRF are demographic details ofthe patient, surgeon and institution/s detail, preoperativedeformity and range of movement of the affected joint,co-morbidities and preoperative ambulatory status ofthe patient, anesthesia ASA grading. Scoring systemsuse for hip joint is Harris Hip score and for the knee jointare knee functional score. Other components includediagnosis and procedure details, whether the surgeryis primary or revision, thromboprophylaxis, antibioticsand postoperative pain management. Details of eachprosthetic joint component, design and company arealso noted. Preoperative and postoperative pictures canalso be recorded in online software version. A separateform is designed for the follow up visit recording of thepatient at 2 weeks, 6 weeks, 3 months, 6 months, 01 year,5 years, 10 years, 15 years and 20 years.The data is being kept and monitored by the MetricsResearch Pvt. limited who are the official researchpartner of PAS.6 Registry development and data collection tools29

Section VII

40Introduction to PAS and PNJR1

Section VIIChallenges in Establishing a Joint Registry.There were multiple challenges in establishing thePNJR. Starting from campaigning, it was a daunting taskto gather a group of like minded surgeons to think onthe same lines and be committed enough to achieve asustainable registry. We knew in our minds that manysmaller and more developed countries have tried toestablish national joint registries but have failed dueto non-cooperation from PI’s. Therefore we startedby campaigning to convince surgeons and hospitalsto participate actively to make this project a success.Similarly, we encouraged implant vendors and suppliersto support the registry so that we could communicateto surgeons across the country through their alreadyestablished sales network.The next challenge was securing a registry software.Multiple options were looked into. Imported softwarewas both expensive and did not necessarily meet ourentire requirements. For this our research partnerMetrics Research took an initiative and we embarked ondeveloping local registry software. This saved the societya lot of revenue that could then be utilized on otherareas such as printing costs for case report forms (CRF’s),transportation, mails and communication. In all we hadto plan to make this a financially sustainable project.Had capital been invested in purchasing an expensivesoftware, we would have spent unnecessary money.steering committee before deciding on the variablesthat need to be included in the final version. We werefaced with the challenge of keeping the form simple yetcomprehensive. We now have a very effective form thatengages ample number of variables without making itlabor intensive.Finally the training of PI’s and hospital staff has takenpriority in the first year of operation of the PNJR.We provided training via video conferencing to PI’sparticipating in the registry especially those who areusing the online version of the eCRF.We feel that a grand project like the PNJR requiressupport from the whole orthopaedic community andfrom arthroplasty surgeons specifically to meet thecurrent and upcoming challenges and to make this asymbol of national pride.Thirdly we had to conform to Good Clinical Practice(ICH-GCP) guidelines for institutional research involvinghuman subjects. We also had local institutional policiesregarding confidentiality of data and data sharingto comply to. We sought Institutional Review Boardapproval and the registry was granted approval by IndusHospital IRB.We also had to develop research tools such as InformedConsent Forms (ICF’s) that were both simple andsensitive to linguistics. Therefore the national languageUrdu was used as first translation. The PAS secretariat isfurther committed to develop forms in local languagesif requested by any PI. The development of the CRF’stook a lot of doing. Many samples were reviewed by the7Challenges in Establishing a Joint Registry33

Section I

Section IPrimary Total Knee ArthroplastyFigure 1.0Figure 1.11Primary Total Knee Arthroplasty37

Figure 1.2Table 3.4Figure 1.3Pre-Operative38Primary Total Knee Arthroplasty1

Figure 1.4Figure 1.51 Primary Total Knee Arthroplasty39

Figure 1.6Figure 1.740Primary Total Knee Arthroplasty1

Figure 1.8Figure 1.91 Primary Total Knee Arthroplasty41

Section II

52 Introduction to PAS and PNJR1

Section IIRevision Total Knee ArthroplastyFigure 2.0Figure 2.1Revision Total Knee Arthroplasty continue to grow as arthroplasty surgeries have been takingplace in the country for over two decades. Currently infection and aseptic lossening form thetwo main reasons for failure of primary total knee arthroplasties.2 Revision Total Knee Arthroplasty45

Figure 2.2Figure 2.346Revision Total Knee Arthroplasty2

Section III

Section IIIPrimary Total Hip ArthroplastyFigure 3.0Figure 3.13Primary Total Hip Arthroplasty49

Figure 3.2Figure 3.350Primary Total Hip Arthroplasty3

Figure 3.4Figure 3.53 Primary Total Hip Arthroplasty51

Figure 3.6Figure 3.752Primary Total Hip Arthroplasty3

Figure 3.8Figure 3.93 Primary Total Hip Arthroplasty53

Figure 3.10Figure 3.1154Primary Total Hip Arthroplasty3

Figure 3.12Figure 3.133 Primary Total Hip Arthroplasty55

Figure 3.14Figure 3.1556Primary Total Hip Arthroplasty3

Figure 3.16FWBNWBFigure 3.173 Primary Total Hip Arthroplasty57

Section IV

Section IVRevision Total Hip ArthroplastyFigure 4.0Figure 4.1Revision hip surgeries are becoming more and more common. Most common form ofrevision is after a

MBBS, MRCS, FCPS (Orth) Assistant. Professor Department of Orthopaedics, Liaquat National Hospital and Medical College, Karachi 4 Dr. Imran Shabir Mughal MBBS, FCPS (Orth) National Fellow, Pakistan Arthroplasty Society Senior Registrar Department of Orthopaedics, Lahore General Hospital, Lahore. 5 Dr. M. Kazim Rahim Najjad MBBS, MD, FCPS (Orth)