Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-01 @ 3:26 AM
Study NCT ID:
NCT05603728
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2022-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exactech Shoulder Post Market Clinical Follow-up Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010020', 'term': 'Osteonecrosis'}, {'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}, {'id': 'D000070656', 'term': 'Rotator Cuff Tear Arthropathy'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D002805', 'term': 'Chondrocalcinosis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2022-10-25', 'studyFirstSubmitQcDate': '2022-11-01', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constant', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'Constant Shoulder Score - 100 points scale about pain, Activities of daily living, Strength test, and Range of Motions questions about shoulder where 100 % corresponds to the highest pain'}, {'measure': 'ASES', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'American Shoulder and Elbow Surgeons Score (ASES) - 100 points scale about shoulder pain and performance evaluation in activities of daily living where 100 indicates the best shoulder condition'}, {'measure': 'Oxford Score (may be used as an optional form for surgeons in the United Kingdom)', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': "Oxford Shoulder Score (OSS) - 12 questions assessing outcomes of shoulder surgery and its impact on patients' quality of life of degenerative conditions such as arthritis and rotator cuff problems - Maximum score is 60 and indicates greater degree of disability"}, {'measure': 'TESS (may be used as specific forms related to the pre-operative condition/diagnosis)', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'Toronto Extremity Salvage Score (TESS) - Patient functional assessment following for surgery for musculoskeletal tumors (Humeral Reconstruction Stem only) - 100-point score where higher score indicates a better outcome'}, {'measure': 'MSTS (may be used as specific forms related to the pre-operative condition/diagnosis)', 'timeFrame': 'Through study completion, an average of 1 per year', 'description': 'Musculoskeletal Tumor Society (MSTS) - 30 points \\[6 times (range 0-5)\\], simple measure of the upper extremity function (Humeral Reconstruction Stem only) - The maximum corresponds to the best score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteo Arthritis Shoulders', 'Osteonecrosis', 'Rotator Cuff Tears', 'Rotator Cuff Tear Arthropathy', 'Ankylosing Spondylitis', 'Post-traumatic Osteoarthritis', 'Rheumatoid Arthritis', 'Fracture', 'Infections']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who meet eligibility criteria - Patients who consent to participate to return for follow-up visits out to 10 years or longer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)\n* Patient is skeletelly mature\n* Patient is expected to survive at least 2 years beyond surgery\n* Patient is willing to participate by complying with pre- and postoperative visit requirements\n* Patient is willing and able to read and sign a study informed consent form\n\nExclusion Criteria:\n\n* Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolved\n* Inadequate or malformed bone that precludes adequate support or fixation of the prosthesis\n* Medial humeral bone loss resulting in compromised humeral stem fixation\n* Proximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixation\n* Neuromuscular disorders that do not allow control of the joint\n* Significant injury to the brachial plexus\n* Non-functional deltoid muscles\n* Patient's age, weight, or activity level would cause the surgeon to expect early failure of the system\n* The patient is unwilling or unable to comply with the post-operative care instructions\n* Alcohol, drug, or other subtance abuse\n* Any disease state that could adversaly affect the function or longevity of the implant\n* Patient is pregnant\n* Patient is a prisoner\n* Patient is contraindicated for the surgery\n* Revision cases in which a stemmed humeral component was used (Stemless Shoulder System)\n* Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)\n* Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)\n* Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)"}, 'identificationModule': {'nctId': 'NCT05603728', 'briefTitle': 'Exactech Shoulder Post Market Clinical Follow-up Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exactech'}, 'officialTitle': 'An Open Label, Multi-Center, Retrospective and Prospective Evaluation of Shoulder Arthroplasty Clinical and Radiographic Outcomes', 'orgStudyIdInfo': {'id': 'CR09-005'}}, 'contactsLocationsModule': {'locations': [{'zip': '92637', 'city': 'Laguna Woods', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '949-586-3200'}], 'facility': 'South County Orthopedic Specialists', 'geoPoint': {'lat': 33.6103, 'lon': -117.72533}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Ramakrishnan', 'role': 'CONTACT', 'phone': '650-723-5643'}], 'facility': 'Stanford Health Care', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '95204-5508', 'city': 'Stockton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Alpine Orthopaedic Medical Group', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Libby Mauter', 'role': 'CONTACT', 'phone': '303-321-1333'}], 'facility': 'Western Orthopaedics', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80525', 'city': 'Fort Collins', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Josh Orr', 'role': 'CONTACT', 'phone': '940-419-7050'}], 'facility': 'Orthopaedic and Spine Center of the Rockies', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '32607', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aimee Struk', 'role': 'CONTACT', 'phone': '352-273-7001'}], 'facility': 'UF Health Orthopaedics and Sports Medicine Institute', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennnifer Wirtz', 'role': 'CONTACT', 'phone': '904-953-2000'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33401', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Meg Ryan', 'role': 'CONTACT', 'phone': '561-657-4610'}], 'facility': 'Palm Beach Orthopaedic Institute', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '33410', 'city': 'Palm Beach Gardens', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rachel Routman', 'role': 'CONTACT', 'phone': '561-627-8500'}], 'facility': 'Florida Atlantis Orthopedics', 'geoPoint': {'lat': 26.82339, 'lon': -80.13865}}, {'zip': '33619', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kendra Richerdson', 'role': 'CONTACT', 'phone': '813-684-2663'}], 'facility': 'Orthopaedic Medical Group of Tampa Bay', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elizabeth Barker', 'role': 'CONTACT', 'phone': '706-223-1493'}], 'facility': 'Orthopedic and Sports Medicine', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Timothy Nelligan', 'role': 'CONTACT', 'phone': '815-398-9491'}], 'facility': 'OrthoIllinois', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}, {'zip': '60195', 'city': 'Schaumburg', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Barrington Orthpedic Specialists', 'geoPoint': {'lat': 42.03336, 'lon': -88.08341}}, {'zip': '48067', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Johnny Kasto', 'role': 'CONTACT', 'phone': '800-436-7936'}], 'facility': 'Henry Ford Health', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '212-598-6000'}], 'facility': 'Hospital for Joint Diseases - NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10011', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Johnathan Joseph', 'role': 'CONTACT', 'phone': '646-665-6000'}], 'facility': 'Lenox Health Greenwich Village', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rebecca Rathbone', 'role': 'CONTACT', 'phone': '828-274-4555'}], 'facility': 'Southeastern Sports Medicine and Orthopedics', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Duke Department of Orthopedic Surgery', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44333', 'city': 'Akron', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ginny Texter', 'role': 'CONTACT', 'phone': '330-668-4040'}], 'facility': 'Crystal Clinic Orthopaedic', 'geoPoint': {'lat': 41.08144, 'lon': -81.51901}}, {'zip': '29414', 'city': 'Charleston', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lisa Mock', 'role': 'CONTACT', 'phone': '843-769-2000'}], 'facility': 'Charleston Orthopaedic Associates', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kyle Adams', 'role': 'CONTACT', 'phone': '864-454-7422'}], 'facility': 'Steadman Hawkins Clinic of the Carolinas', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '37067', 'city': 'Franklin', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kristin Freeman', 'role': 'CONTACT', 'phone': '615-791-2630'}], 'facility': 'Bone and Joint Institute of Tenessee', 'geoPoint': {'lat': 35.92506, 'lon': -86.86889}}, {'zip': '23320', 'city': 'Virginia Beach', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brice Snyder', 'role': 'CONTACT', 'phone': '757-321-3300'}], 'facility': 'Atlantic Orthopaedics Specialists', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '53072', 'city': 'Pewaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ryann Hamm', 'role': 'CONTACT', 'phone': '262-303-5055'}], 'facility': 'Orthopaedic Associates of Wisconsin', 'geoPoint': {'lat': 43.08057, 'lon': -88.2612}}, {'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'facility': "St Joseph's Health Care", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': '87039', 'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Estelle Tillet', 'role': 'CONTACT', 'phone': '33 5 55 45 48 24'}], 'facility': 'Clinique Chenieux', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '33700', 'city': 'Mérignac', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Diane Deplanque', 'role': 'CONTACT', 'phone': '33 5 35 38 97 09'}], 'facility': "Centre de l'arthrose", 'geoPoint': {'lat': 44.84247, 'lon': -0.64512}}, {'zip': '35043', 'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tewfik Benkalfate', 'role': 'CONTACT', 'phone': '33 2 99 85 75 75'}], 'facility': 'Clinique Mutualiste La Sagesse', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '95125', 'city': 'Catania', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gionacchino Zappulla', 'role': 'CONTACT', 'phone': '39 095 238111'}], 'facility': 'Policlinico Morgagni', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '84025', 'city': 'Eboli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Ascione', 'role': 'CONTACT', 'phone': '39 0828 348111'}], 'facility': 'Campolongo Hospital', 'geoPoint': {'lat': 40.61747, 'lon': 15.05693}}, {'zip': 'RG2 7AU', 'city': 'Reading', 'state': 'Berks', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Richard Forbes', 'role': 'CONTACT', 'phone': '0118 922 6888'}], 'facility': 'Circle Health Group', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}, {'zip': 'BA21 4AT', 'city': 'Yeovil', 'state': 'Summerset', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Oliver Donaldson', 'role': 'CONTACT', 'phone': '01935 475122'}], 'facility': 'Yeovil District Hospital NHS Foundation Trust', 'geoPoint': {'lat': 50.94159, 'lon': -2.63211}}, {'zip': 'BA2 8SQ', 'city': 'Bath', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Darren James', 'role': 'CONTACT', 'phone': '01761 422222'}], 'facility': 'The Sulis Hospital Bath', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'MK42 9DJ', 'city': 'Bedford', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Bedford Hospital', 'geoPoint': {'lat': 52.13459, 'lon': -0.46632}}, {'zip': 'IP4 5PD', 'city': 'Ipswich', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'David B Smith', 'role': 'CONTACT', 'phone': '01473 712233'}], 'facility': 'Ipswich Hospital', 'geoPoint': {'lat': 52.05917, 'lon': 1.15545}}, {'zip': 'LE5 4PW', 'city': 'Leicester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Leicester General Hospital', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Rebecca Carter', 'role': 'CONTACT', 'phone': '0161 945 8203'}], 'facility': 'University Hospital South Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Nottingham', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Donna King', 'role': 'CONTACT', 'phone': '0115 924 9924'}], 'facility': 'Nottingham University Hospital', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'Rachael Craig', 'role': 'CONTACT', 'email': 'rachael.craig@exac.com', 'phone': '352-377-1140'}, {'name': 'Sandrine Angibaud', 'role': 'CONTACT', 'email': 'sandrine.angibaud@exac.com', 'phone': '352-377-1140'}], 'overallOfficials': [{'name': 'Jonathan Wright, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UF Health Orthopaedics and Sports Medicine Institute'}, {'name': 'Young Kwon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Joint Diseases - NYU Langone Health'}, {'name': 'Richard Friedman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charleston Orthopaedic Associates'}, {'name': 'Richard Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southeastern Orthopedics and Spine'}, {'name': 'Howard Routman, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Atlantis Orthopaedics'}, {'name': 'Ryan Simovitch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Palm Beach Orthopaedic Institute'}, {'name': 'Geoffrey Abrams, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford Health Care'}, {'name': 'Pierre Henri Flurin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre de l'Arthrose"}, {'name': 'Yann Marczuk, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Chenieux'}, {'name': 'Harry Brownlow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Circle Health Group'}, {'name': 'Oliver Donaldson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeovil District Hospital NHS Foundation'}, {'name': 'Chris Roberts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ipswich Hospital'}, {'name': 'Chris Peach, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital South Manchester'}, {'name': 'Angelo Di Giunta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Morgagni'}, {'name': 'Alfonso Romano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Campolongo Hospital'}, {'name': 'Sean Grey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic and Spine Center of the Rockies'}, {'name': 'Chad Manke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altantic Orthopaedics Specialists'}, {'name': 'Rick Papandrea, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic Associates of Wisconsin'}, {'name': 'Andrew Chambler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Sulis Hospital Bath'}, {'name': 'Curt Noel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Crystal Clinic Orthopaedic'}, {'name': 'Stephen Parada, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopedic and Sports Medicine'}, {'name': 'Ari Youderian, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South County Orthopedic Specialists'}, {'name': 'Ian Byram, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bone and Joint Institute of Tennessee'}, {'name': 'Tewfik Benkalfate, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Mutualiste la Sagesse'}, {'name': 'Peter McCann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lenox Health Greenwich Village'}, {'name': 'Stephanie Muh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Henry Ford Health'}, {'name': 'Bradley Schoch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Stephan Pill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steadman Hawkins Clinic of the Carolinas'}, {'name': 'Scott Trenhaile, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OrthoIllinois'}, {'name': 'Bryan Butler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orthopaedic Medical Group of Tampa Bay'}, {'name': 'Ben Gooding, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottingham City Hospital'}, {'name': 'Brad Carofino, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Altantic Orthopaedics Specialist'}, {'name': 'Ben Sears, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Orthopaedics'}, {'name': 'Kenneth Faber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Joseph's Health Care"}, {'name': 'Jaicharan Iyengar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alpine Orthopaedic Medical Group'}, {'name': 'Oke Anakwenze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke Department of Orthopedic Surgery'}, {'name': 'Thomas Obermeyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Barrington Orthopedic'}, {'name': 'Alison Armstrong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leicester General Hospital'}, {'name': 'George Malal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bedford Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exactech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}