Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT05530551
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-05
First Post:
2022-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-06', 'size': 1412548, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-28T11:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blinding will not be applicable, because it is considered infeasible to expose participants and clinical personnel to this in either of the groups since any specific clinic will follow their allocated specific (single- or multiple-dose) routine during an entire 1-year period and their routine treatment of any complication (before switching).'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The Pro-Hip-Quality Trial is a Cluster Randomized Trial with an embedded Cross-Over Design where each clinical center (C: 1, 2, 3, …., 36 individual sites) will be running a specific intervention (i.e. single- or multiple-dose antibiotics) throughout 12 months, and the subsequent year the clinical department will automatically switch to the opposite intervention (i.e. multiple- or single-dose antibiotics).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2022-08-30', 'studyFirstSubmitQcDate': '2022-09-03', 'lastUpdatePostDateStruct': {'date': '2025-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incremental cost-effectiveness', 'timeFrame': 'Within 90 days from index surgery', 'description': 'The incremental cost-effectiveness will be calculated based on the costs per patient in the two antibiotic practices. Costs related to antibiotic prophylaxis, hospital admissions and readmissions, hospital outpatient visits, visits to General practitioner and costs related to sick leave from work will be included.\n\nData will be collected from:\n\n* The Danish National Patient Registry (DNPR)\n* The Civil Registration System (CRS)\n* The Danish Agency for Labor Market and Recruitment registry STAR'}, {'measure': 'Rate of revision after THA', 'timeFrame': 'Within 1 year from index surgery', 'description': 'Revision surgery is defined as a new surgical intervention the first time after the primary intervention including debridement alone or in combination with complete or partial removal or exchange of the implant. The rate of revision is recorded from The Danish Hip Arthroplasty Registry (DHR) and The Danish National Patient Registry (DNRP). Revision due to any cause including PJI and aseptic loosening will be included.'}, {'measure': 'Mortality rate after index surgery', 'timeFrame': 'Within 1 year from index surgery', 'description': '1-year mortality rate is defined by date of death due to any cause after index surgery. Data is collected from The Civil Registration System (CRS).'}, {'measure': 'Incidence of Superficial incisional Surgical Site Infection', 'timeFrame': 'Within 90 days from index surgery', 'description': 'To be defined'}], 'primaryOutcomes': [{'measure': 'Incidence of Prosthetic joint infections (PJI)', 'timeFrame': 'Within 90 days from index surgery', 'description': 'The definition of PJI is based on revision surgery. Revision surgery is defined as a new surgical intervention the first time after the primary intervention including debridement alone or in combination with complete or partial removal or exchange of the implant.\n\n1. Two or more intraoperative deep-tissue samples of phenotypically indistinguishable bacteria isolated from at least 3 deep-tissue samples\n2. One or more positive intraoperative samples from a closed fluid aspirate AND a biopsy (fluid AND tissue) of phenotypically indistinguishable bacteria isolated\n3. A PJI when an indication of deep infection is reported to The Danish Hip Arthroplasty Registry (DHR) by the surgeon upon revision surgery'}], 'secondaryOutcomes': [{'measure': 'Number of patients with one or more Serious Adverse Events (SAEs)', 'timeFrame': 'Within 90 days from index surgery', 'description': "SAEs are defined according to the ICH-GCP guidelines. SAE refers to an event involving a significant risk of death or disability of the patient (or their offspring), including, but not limited to, an event that:\n\n* results in death\n* is life-threatening - in the investigator's opinion the patient was in immediate risk of death from the adverse event when it appeared\n* requires hospitalization or prolongs existing hospitalization\n* results in permanent or significant disability\n* is a congenital anomaly SAEs are recorded from The Danish National Patient Registry (DNPR)"}, {'measure': 'Incidence of Potential PJI referred to as PJI-likely', 'timeFrame': 'Within 90 days from index surgery', 'description': 'PJI-likely is defined as at least one of the two criteria:\n\n1. One single intraoperatively obtained positive culture (aspiration fluid OR tissue biopsy) regardless of microorganism\n2. One single positive culture obtained from aspiration of synovial fluid regardless of microorganism AND any antibiotic prescriptions (ATC category J01) redeemed'}, {'measure': 'Length of hospital stay (LOS)', 'timeFrame': 'Within 90 days from index surgery', 'description': 'LOS defined as number of postoperative overnight stays, including transferals to other departments and hospitals. Data on LOS is acquired from DNPR.'}, {'measure': 'Incidence of Major Adverse Cardiovascular Events (MACE)', 'timeFrame': 'Within 90 days from index surgery', 'description': 'A MACE is defined a priori to include thromboembolic complications including venous thromboembolism, myocardial infarction, atrial fibrillation and stroke based on the diagnostic ICD10 codes listed in Appendix B. VTE is defined a priori as both deep venous thromboembolisms confirmed by compression ultrasound and pulmonary embolism confirmed by spiral computed tomography (CT), ventilation-perfusion scintigraphy or pathological removal of an embolus and based on the following diagnostic ICD10 codes: I26, I80.1-I80.9, I82.1-I82.9, or T81.7B-D. Data will be extracted from DNPR.'}, {'measure': 'Hospital-treated infections (excluding Surgical Site infections)', 'timeFrame': 'Within 90 days from index surgery', 'description': 'Any Hospital-treated infection is defined as any first-time hospital admission with a primary or secondary infection diagnosis after discharge from index THA surgery. Hospital-treated infections are identified from DNPR.\n\nThe list of infections includes chronic and more rare infections, to detect possible flare-up in any possible ongoing infections.\n\nThe list will exclude urinary tract infections (UTI) due to a high risk of different registration praxis registration for UTI among hospitals in Denmark.'}, {'measure': 'Proportion of patients with at least one dispensing for antibiotic', 'timeFrame': 'Within 90 days from index surgery', 'description': 'Community-based antibiotic use (any community-treated infection or antibiotic use after discharge) is defined as at least one dispensing after discharge from index THA surgery within 90 days for narrow- and broad-spectrum antibiotics based on the Anatomical Therapeutic Chemical classification (ATC) codes. All antibiotics in Denmark require prescriptions from a physician. The Danish National Health Service Prescription Database has registered all reimbursed prescriptions from all community pharmacies since 2004. Medications are coded according to the following ATC codes: J01CE, J01CF, J01DB, J01DC, J01DD, J01DE, J01DH, J01DI, J01CR, J01CA, J01F. J01E, J01MA ,J01AA'}, {'measure': 'Opioid use', 'timeFrame': 'Within 90 days from index surgery', 'description': 'Prescriptions will be identified using NPR. The following ATC codes (including all subcodes) are included: N01AH (opioid anesthetics), N02A (opioids), N07BC02 (methadone), and R05DA04 (codeine). We defined opioid users as patients who redeemed two opioid prescriptions within six months prior to THA surgery. Conversely, patients who did not redeem two or more opioid prescriptions within this timeframe were classified as opioid naïve. For opioid naïve patients, opioid use post-THA is defined as the redemption of two opioid prescriptions within 90 days following surgery. We assert that two separate redeemed prescriptions confirm actual medication use. We will calculate the treatment dosage based on the number of packages and volume redeemed within 90 days post-surgery. To investigate dosages, all doses will be converted to morphine milligram equivalents using a conversion factor specific to the type of opioid.'}, {'measure': 'Use of acetaminophen or non-steroidal anti-inflammatory drugs', 'timeFrame': 'Within 90 days from index surgery', 'description': 'Patients who received at least one prescription for acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs) following THA surgery. Prescriptions of analgesics will be identified using NPR (41). All analgesics in Denmark except 10-tablet packages of acetaminophen / ibuprofen of dose 200mg ibuprofen require prescriptions from a physician. Following ATC codes (including all subcodes) are included M01A (NSAIDs) and N02BE01 (paracetamol). Duration of treatment will be calculated based on number of packages and volume. Since there is no clear definition of acetaminophen or non-steroidal anti-inflammatory users, we define these users as patients who redeemed two prescriptions within 6 months before THA.'}, {'measure': 'Any revision after THA', 'timeFrame': 'Within 90 days from index surgery', 'description': 'Revision surgery is defined as a new surgical intervention the first time after the primary intervention including debridement alone or in combination with complete or partial removal or exchange of any implants. Rate of revision is defined as revision due to any cause within 90 days from primary THA surgery. Any revision will be recorded from DHR and DNPR.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Antibiotic Prophylaxis', 'OA', 'Osteoarthritis', 'Osteoarthritis, Hip', 'Total Hip Replacement', 'Total Hip Arthroplasty', 'Prosthetic Joint Infection', 'PJI', 'Cluster Randomized Controlled Trial', 'Randomized Controlled Trial', 'RCT', 'THA'], 'conditions': ['Osteoarthritis, Hip', 'Total Hip Arthroplasty', 'Prosthetic-joint Infection']}, 'referencesModule': {'references': [{'pmid': '37604637', 'type': 'DERIVED', 'citation': 'Abedi AA, Varnum C, Pedersen AB, Gromov K, Hallas J, Iversen P, Jakobsen T, Jimenez-Solem E, Kidholm K, Kjerulf A, Lange J, Odgaard A, Rosenvinge FS, Solgaard S, Sperling K, Stegger M, Christensen R, Overgaard S. Effect of single versus multiple prophylactic antibiotic doses on prosthetic joint infections following primary total hip arthroplasty in patients with osteoarthritis at public and private hospitals in Denmark: protocol for a nationwide cross-over, cluster randomised, non-inferiority trial [The Pro-Hip-Quality Trial]. BMJ Open. 2023 Aug 21;13(8):e071487. doi: 10.1136/bmjopen-2022-071487.'}]}, 'descriptionModule': {'briefSummary': 'Aim: To compare the effect of one single dose versus multiple doses of prophylactic antibiotics administered within 24 hours, on the development of PJI in patients with osteoarthritis undergoing primary THA.\n\nThe study is designed as a cross-over, cluster randomized, non-inferiority trial. All Danish orthopedic surgery departments performing primary THA with the majority being within inclusion criteria will be involved: Based on national quality databases, two-year cohorts of approximately 20,000 primary THAs conducted at all public and private orthopedic departments in Denmark, this includes 36 sites corresponding to a total of 39 departments.', 'detailedDescription': 'The outcome measures will be extracted from the following national databases: The Civil Registration System (CRS), The Danish Hip Arthroplasty Register (DHR), The Danish National Patient Registry (DNRP), The Hospital Acquired Infections Database (HAIBA), The Danish National Prescription Database (NPR), Statistics Denmark and Danish Agency for Labour Market and Recruitment registry (STAR).\n\nDetails regarding the Arms and Interventions:\n\nThe preoperative dose of antibiotic must be administered prior to surgical incision and in cases of delay with regards to planned surgical incision:\n\nDicloxacillin/Cloxacillin: If the preoperative antibiotic dose is administered \\>60 minutes prior to surgical incision, the initial dose must be repeated.\n\nCefuroxime: If the preoperative antibiotic dose is administered \\>90 minutes prior to surgical incision, the initial dose must be repeated.\n\nTreatment A, Single-dose practice:\n\nFor patients ≥ 120 kg:\n\nOne preoperative single dose of either Dicloxacillin/Cloxacillin 3g OR Cefuroxime 3g administered intravenously prior to surgical incision.\n\nIn cases of cephalosporin allergy or general beta lactam allergy one preoperative single dose of Clindamycin 900mg may be administered intravenously, prior to surgical incision, regardless of weight.\n\nTreatment B, Multiple-dose practice:\n\nFor patients ≥ 120 kg:\n\nOne preoperative single dose of either Dicloxacillin/Cloxacillin 3g OR Cefuroxime 3g administered intravenously prior to surgical incision, followed by 3 postoperative doses of Dicloxacillin/Cloxacillin 2g x 3 OR Cefuroxime 1.5g x 3, administered within 24 hours after the preoperative dose.\n\nAfter the first postoperative dose, the remaining doses may be administered perorally for pragmatic reasons. Administration of peroral doses as followed regardless of weight:\n\nDicloxacillin p.o. 1g, 12 and 18 hours postoperatively. OR Amoxicillin and clavulanic acid p.o. 875mg/125\\*mg, 12 and 18 hours postoperatively.\n\n\\*If the center or region does not have access to amoxicillin and clavulanic acid 875/125mg a dose of 1g / 125mg (this means amoxicillin 500mg + amoxicillin and clavulanic acid 500mg/125 mg) may be administered.\n\nIn cases of cephalosporin allergy or general beta lactam allergy one preoperative single dose of Clindamycin 900mg may be administered intravenously, prior to surgical incision, regardless of weight, followed by 2 postoperative doses corresponding to:\n\nFor patients \\<120kg: 300mg, 8 and 16 hours postoperatively. For patients ≥ 120kg: 600mg, 8 and 16 hours postoperatively. The same doses apply in cases of transmission to peroral antibiotics.\n\nImplementation: The senior biostatistician is responsible for the randomization process of the centers. Each center will be allocated a code by the senior biostatistician responsible and reported to a central database. The randomization and allocation procedure will be known for the given year conditioning the given center.\n\nEthics and Dissemination: This trial has been approved by the Regional Ethical Committee (VEK) (21069108) and The Danish Medicines Agency (2021091723) without imposing an obligation to notify.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. All patients receiving a primary Total Hip Arthroplasty (THA) due to primary and secondary causes of osteoarthritis\n\nExclusion Criteria:\n\n1. Patients receiving a primary THA due to either acute or sequelae of proximal femoral or acetabular fractures\n2. Patients receiving a primary THA due to bone tumor or metastasis'}, 'identificationModule': {'nctId': 'NCT05530551', 'acronym': 'ProHipQ-OA', 'briefTitle': 'Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Bispebjerg and Frederiksberg'}, 'officialTitle': 'The Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With Osteoarthritis: A Cross-over, Cluster Randomized Controlled, Non-inferiority Trial Based on National Quality Databases. ProHipQ-OA', 'orgStudyIdInfo': {'id': 'ProHipQ Osteoarthritis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A, Single-dose practice', 'description': 'One preoperative single dose of either Dicloxacillin/Cloxacillin 2g OR Cefuroxime 1.5g administered intravenously prior to surgical incision.\n\nAs the study is a non-inferiority trial, we have chosen the Experimental design category.', 'interventionNames': ['Other: Antibiotic dosage practice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B, Multiple-dose practice', 'description': 'One preoperative dose of either Dicloxacillin/Cloxacillin 2g OR Cefuroxime 1.5g administered intravenously prior to surgical incision followed by 3 postoperative doses of Dicloxacillin/Cloxacillin 1g x 3 OR Cefuroxime 750mg x 3 within 24 hours after the preoperative dose.', 'interventionNames': ['Other: Antibiotic dosage practice']}], 'interventions': [{'name': 'Antibiotic dosage practice', 'type': 'OTHER', 'description': 'Patient inclusion starts day one, cross-over of departments from treatment A (single-dose) to B (multiple-dose) or vice versa after one year and end of inclusion happens after 2 years.\n\nAll centers in Denmark use either Cloxacillin/Dicloxacillin, Cefuroxime or both drugs as standard prophylactic antibiotic practice for THA. In cases of cephalosporin allergy or general beta lactam allergy, the antibiotic clindamycin may be administered.\n\nIn this trial, patients will be administered the standard prophylactic antibiotic practice of either single-dose (A) or multiple-doses (B) of antibiotics administered at each respective cluster that respective year. Both practices of dose administration for antibiotic prophylaxis (i.e. single- or multiple-dose) follow current standards of treatment and are based on present clinical practice guidelines.', 'armGroupLabels': ['Treatment A, Single-dose practice', 'Treatment B, Multiple-dose practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200/6400', 'city': 'Aabenraa', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Hospital of Southern Jutland, Aabenraa and Sønderborg', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Capio Private Hospital, Aalborg', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Aalborg, Aalborg University Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aleris Private Hospital, Aarhus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Deaprtment of Orthopaedic Surgery, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Capio Private Hospital, Aarhus', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}, {'zip': '2605', 'city': 'Brøndby', 'country': 'Denmark', 'facility': 'Capio Private Hospital, Gildhøj', 'geoPoint': {'lat': 55.6455, 'lon': 12.41008}}, {'zip': '2400', 'city': 'Copenhagen NV', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery and Traumatology, Bispebjerg, Copenhagen University Hospital - Bispebjerg and Frederiksberg'}, {'zip': '2100', 'city': 'Copenhagen Ø', 'country': 'Denmark', 'facility': 'Adeas Private Hospital, Parken'}, {'zip': '6700', 'city': 'Esbjerg', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Esbjerg, Hospital of South West Jutland', 'geoPoint': {'lat': 55.47028, 'lon': 8.45187}}, {'zip': '9640', 'city': 'Farsø', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Farsø, Aalborg University Hospital', 'geoPoint': {'lat': 56.77276, 'lon': 9.33925}}, {'zip': '3520', 'city': 'Farum', 'country': 'Denmark', 'facility': 'CPH Private Hospital', 'geoPoint': {'lat': 55.80858, 'lon': 12.36066}}, {'zip': '9900', 'city': 'Frederikshavn', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Frederikshavn, Aalborg University Hospital', 'geoPoint': {'lat': 57.44073, 'lon': 10.53661}}, {'zip': '7200', 'city': 'Grindsted', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Grindsted, Hospital of South West Jutland', 'geoPoint': {'lat': 55.75726, 'lon': 8.9275}}, {'zip': '2900/5000', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Capio Private Hospital, Hellerup and Odense', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Department of Orthopaedic Surgery, Gentofte, Copenhagen University Hospital - Herlev and Gentofte', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}, {'zip': '2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Department of Orthopaedic Surgery, Herlev, Copenhagen University Hospital - Herlev and Gentofte', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '7400', 'city': 'Herning', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Gødstrup Regional Hospital', 'geoPoint': {'lat': 56.13615, 'lon': 8.97662}}, {'zip': '3400', 'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Hillerød, Copenhagen University Hospital - North Zealand', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'zip': '4300', 'city': 'Holbæk', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Copenhagen University Hospital - Holbæk', 'geoPoint': {'lat': 55.7175, 'lon': 11.71279}}, {'zip': '8700', 'city': 'Horsens', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Horsens Regional Hospital, Denmark', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}, {'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Hvidovre, Copenhagen University Hospital - Amager and Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}, {'zip': '2800', 'city': 'Kongens Lyngby', 'country': 'Denmark', 'facility': 'Acure Private Hospital', 'geoPoint': {'lat': 55.77044, 'lon': 12.50378}}, {'zip': '6340', 'city': 'Kruså', 'country': 'Denmark', 'facility': 'Kollund Private Hospital, Kollund', 'geoPoint': {'lat': 54.85097, 'lon': 9.40129}}, {'zip': '4600', 'city': 'Køge', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Zealand University Hospital, Køge', 'geoPoint': {'lat': 55.45802, 'lon': 12.18214}}, {'zip': '4800', 'city': 'Nykøbing Falster', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery, Copenahegn University Hospital - Nykøbing F', 'geoPoint': {'lat': 54.76906, 'lon': 11.87425}}, {'zip': '4700', 'city': 'Næstved', 'country': 'Denmark', 'facility': 'Department for Planned Orthopaedic Surgery, Næstved, Copenhagen University Hospital - Næstved, Slagelse and Ringsted', 'geoPoint': {'lat': 55.22992, 'lon': 11.76092}}, {'zip': '5000/5700', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Department of Orthopedic Surgery and Traumatology, Odense University Hospital and Svendborg Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'zip': '8930', 'city': 'Randers', 'country': 'Denmark', 'facility': 'Deparmtent of Orthopedic Surgery, Randers Regional Hospital', 'geoPoint': {'lat': 56.4607, 'lon': 10.03639}}, {'zip': '4100', 'city': 'Ringsted', 'country': 'Denmark', 'facility': 'Aleris Private Hospital, Ringsted', 'geoPoint': {'lat': 55.4426, 'lon': 11.79011}}, {'zip': '3700', 'city': 'Rønne', 'country': 'Denmark', 'facility': 'Department of Surgery, Copenhagen University Hospital - Bornholm', 'geoPoint': {'lat': 55.10091, 'lon': 14.70664}}, {'zip': '8600', 'city': 'Silkeborg', 'country': 'Denmark', 'facility': 'Center for Planned Surgery, Silkeborg Regional Hospital', 'geoPoint': {'lat': 56.1697, 'lon': 9.54508}}, {'zip': '2860', 'city': 'Søborg', 'country': 'Denmark', 'facility': 'Aleris Private Hospital, Søborg', 'geoPoint': {'lat': 56.08481, 'lon': 12.31803}}, {'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Department of Orthopedics, Lillebaelt Hospital, Vejle', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Mølholm Private Hospital, Vejle', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}, {'zip': '8800', 'city': 'Viborg', 'country': 'Denmark', 'facility': 'Deparmtent of Orthopedic Sugery, Viborg Regional Hospital', 'geoPoint': {'lat': 56.45319, 'lon': 9.40201}}], 'overallOfficials': [{'name': 'Armita A Abedi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Copenhagen University Hospital Bispebjerg, Department of Orthopaedic Surgery and Traumatology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Immediately following publication, no end date.', 'ipdSharing': 'YES', 'description': 'Access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), will be provided to anyone who wishes to access the data.', 'accessCriteria': 'Anyone who wishes to access the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soren Overgaard', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'University Hospital Bispebjerg and Frederiksberg', 'class': 'OTHER'}, {'name': 'Odense University Hospital', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, {'name': 'University of Aarhus', 'class': 'OTHER'}, {'name': 'Sygehus Lillebaelt', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor, DMSc', 'investigatorFullName': 'Soren Overgaard', 'investigatorAffiliation': 'University Hospital Bispebjerg and Frederiksberg'}}}}