Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT03649360
Status:
COMPLETED
Last Update Posted:
2018-08-28
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Knee Pain After Intramedullary Nailing in the Tibia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013978', 'term': 'Tibial Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2016-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-25', 'studyFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2018-08-25', 'lastUpdatePostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Pain after Tibial Shaft Fracture Treated with Intramedullary Nailing', 'timeFrame': '1st of November 2009 till 30th of October 2014.', 'description': "The primary objective of this study is to evaluate the long-term outcome after inserting an IMN in patients with a tibial shaft fracture using an injury-specific questionnaire. We used the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire to collect patient data. It is used to assess patient's subjective opinion about symptoms related to the knee and other associated problems. The questionnaire has been translated and validated in Danish and consists of 5 subscales: pain, symptoms, function in daily living (ADL) function in sports and recreation and knee-related QOL. Each subscale has between 4 and 17 questions (a total of 42 questions) with each question having 5 options ranging from no symptoms to severe symptoms. Each question gets a score from 0-4 and a score from 0-100 is calculated. 100 indicating no symptoms and 0 indicates major symptoms."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee pain', 'Intramedullary tibial nail', 'KOOS'], 'conditions': ['Tibia Fracture', 'Knee Pain Chronic']}, 'referencesModule': {'references': [{'pmid': '3733776', 'type': 'BACKGROUND', 'citation': 'Bone LB, Johnson KD. Treatment of tibial fractures by reaming and intramedullary nailing. J Bone Joint Surg Am. 1986 Jul;68(6):877-87.'}, {'pmid': '9314395', 'type': 'BACKGROUND', 'citation': 'Bone LB, Sucato D, Stegemann PM, Rohrbacher BJ. Displaced isolated fractures of the tibial shaft treated with either a cast or intramedullary nailing. An outcome analysis of matched pairs of patients. J Bone Joint Surg Am. 1997 Sep;79(9):1336-41. doi: 10.2106/00004623-199709000-00007.'}, {'pmid': '9057144', 'type': 'BACKGROUND', 'citation': 'Court-Brown CM, Gustilo T, Shaw AD. Knee pain after intramedullary tibial nailing: its incidence, etiology, and outcome. J Orthop Trauma. 1997 Feb-Mar;11(2):103-5. doi: 10.1097/00005131-199702000-00006.'}, {'pmid': '22052645', 'type': 'BACKGROUND', 'citation': 'Hiesterman TG, Shafiq BX, Cole PA. Intramedullary nailing of extra-articular proximal tibia fractures. J Am Acad Orthop Surg. 2011 Nov;19(11):690-700. doi: 10.5435/00124635-201111000-00005.'}, {'pmid': '18758282', 'type': 'BACKGROUND', 'citation': 'Lefaivre KA, Guy P, Chan H, Blachut PA. Long-term follow-up of tibial shaft fractures treated with intramedullary nailing. J Orthop Trauma. 2008 Sep;22(8):525-9. doi: 10.1097/BOT.0b013e318180e646.'}, {'pmid': '11940618', 'type': 'BACKGROUND', 'citation': 'Toivanen JA, Vaisto O, Kannus P, Latvala K, Honkonen SE, Jarvinen MJ. Anterior knee pain after intramedullary nailing of fractures of the tibial shaft. A prospective, randomized study comparing two different nail-insertion techniques. J Bone Joint Surg Am. 2002 Apr;84(4):580-5. doi: 10.2106/00004623-200204000-00011.'}, {'pmid': '10852322', 'type': 'BACKGROUND', 'citation': 'Karladani AH, Granhed H, Edshage B, Jerre R, Styf J. Displaced tibial shaft fractures: a prospective randomized study of closed intramedullary nailing versus cast treatment in 53 patients. Acta Orthop Scand. 2000 Apr;71(2):160-7. doi: 10.1080/000164700317413139.'}, {'pmid': '20205366', 'type': 'BACKGROUND', 'citation': 'Morandi M, Banka T, Gaiarsa GP, Guthrie ST, Khalil J, Hoegler J, Lindeque BG. Intramedullary nailing of tibial fractures: review of surgical techniques and description of a percutaneous lateral suprapatellar approach. Orthopedics. 2010 Mar;33(3):172-9. doi: 10.3928/01477447-20100129-22. No abstract available.'}, {'pmid': '10831746', 'type': 'BACKGROUND', 'citation': 'Karachalios T, Babis G, Tsarouchas J, Sapkas G, Pantazopoulos T. The clinical performance of a small diameter tibial nailing system with a mechanical distal aiming device. Injury. 2000 Jul;31(6):451-9. doi: 10.1016/s0020-1383(00)00024-3.'}, {'pmid': '16645100', 'type': 'BACKGROUND', 'citation': 'Katsoulis E, Court-Brown C, Giannoudis PV. Incidence and aetiology of anterior knee pain after intramedullary nailing of the femur and tibia. J Bone Joint Surg Br. 2006 May;88(5):576-80. doi: 10.1302/0301-620X.88B5.16875. No abstract available.'}, {'pmid': '18545115', 'type': 'BACKGROUND', 'citation': 'Vaisto O, Toivanen J, Kannus P, Jarvinen M. Anterior knee pain after intramedullary nailing of fractures of the tibial shaft: an eight-year follow-up of a prospective, randomized study comparing two different nail-insertion techniques. J Trauma. 2008 Jun;64(6):1511-6. doi: 10.1097/TA.0b013e318031cd27.'}, {'pmid': '12439190', 'type': 'BACKGROUND', 'citation': 'Althausen PL, Neiman R, Finkemeier CG, Olson SA. Incision placement for intramedullary tibial nailing: an anatomic study. J Orthop Trauma. 2002 Nov-Dec;16(10):687-90. doi: 10.1097/00005131-200211000-00001.'}, {'pmid': '19359927', 'type': 'BACKGROUND', 'citation': 'Weninger P, Schultz A, Traxler H, Firbas W, Hertz H. Anatomical assessment of the Hoffa fat pad during insertion of a tibial intramedullary nail--comparison of three surgical approaches. J Trauma. 2009 Apr;66(4):1140-5. doi: 10.1097/TA.0b013e318169cd4d.'}, {'pmid': '10697311', 'type': 'BACKGROUND', 'citation': 'Hernigou P, Cohen D. Proximal entry for intramedullary nailing of the tibia. The risk of unrecognised articular damage. J Bone Joint Surg Br. 2000 Jan;82(1):33-41. doi: 10.1302/0301-620x.82b1.9818.'}, {'pmid': '7593119', 'type': 'BACKGROUND', 'citation': "Orfaly R, Keating JE, O'Brien PJ. Knee pain after tibial nailing: does the entry point matter? J Bone Joint Surg Br. 1995 Nov;77(6):976-7. No abstract available."}, {'pmid': '16702914', 'type': 'BACKGROUND', 'citation': 'Bhattacharyya T, Seng K, Nassif NA, Freedman I. Knee pain after tibial nailing: the role of nail prominence. Clin Orthop Relat Res. 2006 Aug;449:303-7. doi: 10.1097/01.blo.0000223976.91089.08.'}, {'pmid': '21886000', 'type': 'BACKGROUND', 'citation': 'Ryan SP, Tornetta P 3rd, Dielwart C, Kaye-Krall E. Knee pain correlates with union after tibial nailing. J Orthop Trauma. 2011 Dec;25(12):731-5. doi: 10.1097/BOT.0b013e318213f587.'}, {'pmid': '21762062', 'type': 'BACKGROUND', 'citation': 'Demirtas A, Azboy I, Durakbasa MO, Ucar BY, Mercan AS, Cakir IA. [The relationship between the quadriceps muscle strength and the anterior knee pain occurring after locked intramedullary nailing for tibial diaphysis fractures]. Eklem Hastalik Cerrahisi. 2011 Aug;22(2):81-4. Turkish.'}, {'pmid': '17473752', 'type': 'BACKGROUND', 'citation': 'Vaisto O, Toivanen J, Kannus P, Jarvinen M. Anterior knee pain and thigh muscle strength after intramedullary nailing of a tibial shaft fracture: an 8-year follow-up of 28 consecutive cases. J Orthop Trauma. 2007 Mar;21(3):165-71. doi: 10.1097/BOT.0b013e31803773cd.'}, {'pmid': '445918', 'type': 'BACKGROUND', 'citation': 'Weller S, Kuner E, Schweikert CH. Medullary nailing according to Swiss study group principles. Clin Orthop Relat Res. 1979 Jan-Feb;(138):45-55.'}, {'pmid': '4609657', 'type': 'BACKGROUND', 'citation': 'Lottes JO. Medullary nailing of the tibia with the triflange nail. Clin Orthop Relat Res. 1974 Nov-Dec;(105):53-66. No abstract available.'}, {'pmid': '16670005', 'type': 'BACKGROUND', 'citation': 'Paradowski PT, Bergman S, Sunden-Lundius A, Lohmander LS, Roos EM. Knee complaints vary with age and gender in the adult population. Population-based reference data for the Knee injury and Osteoarthritis Outcome Score (KOOS). BMC Musculoskelet Disord. 2006 May 2;7:38. doi: 10.1186/1471-2474-7-38.'}, {'pmid': '31315794', 'type': 'DERIVED', 'citation': 'Erin-Madsen N, Aasvang TK, Viberg B, Bloch T, Brix M, Tengberg PT. Knee pain and associated complications after intramedullary nailing of tibial shaft fracture. Dan Med J. 2019 Aug;66(8):A5554.'}], 'seeAlsoLinks': [{'url': 'http://www.koos.nu', 'label': 'KOOS questionnaire \\[KOOS web site\\]. Accessed May 20th 2015.'}, {'url': 'http://www.DFDB.dk', 'label': 'Danish Database of Fractures website. Accessed March 25, 2015.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the long-term outcome after inserting an intramedullary nail in patients with a tibial shaft fracture using an injury-specific questionnaire.', 'detailedDescription': 'Introduction\n\nThe treatment of choice for unstable diaphyseal fractures in the tibia is reamed insertion of an intramedullary nail (IMN) with the additional placement of interlocking screws. The most common complication after insertion of an IMN as treatment of tibial shaft fractures is chronic knee pain with reported rates between 10 % and 87 % with a mean of 47,4 % in metaanalyses.\n\nMethods\n\nThe primary objective of this study is to evaluate the long-term outcome after inserting an IMN in patients with a tibial shaft fracture using an injury-specific questionnaire.\n\nThis study includes patients operated on five Danish hospitals. A database search was made using operational codes for insertion of an IMN in a five-year period. Patients aged 18 years or older, alive and residing in Denmark at the time of follow-up could be included in the study. These patients then received a Knee Injury and Osteoarthritis Score (KOOS) questionnaire by mail with questions regarding knee-specific symptoms, stiffness, pain, function and quality of life. Questionnaires were filled out and returned to the corresponding physician for further analyze. Patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who underwent surgery with reamed, locked intramedullary nailing after isolated tibial shaft fracture at one of the above mentioned orthopedic departments between 1st of November 2009 and 30th of October 2014 were sought.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 years or older, alive and residing in Denmark at the time of follow-up could be included in the study.\n\nExclusion Criteria:\n\n* Patients who were unable to fill out the questionnaire due to concomitant physical condition or who had undergone amputation or further surgery on the affected limb were excluded.'}, 'identificationModule': {'nctId': 'NCT03649360', 'briefTitle': 'Knee Pain After Intramedullary Nailing in the Tibia', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital, Hvidovre'}, 'officialTitle': 'Knee Pain After Tibial Shaft Fracture Treated With Intramedullary Nailing', 'orgStudyIdInfo': {'id': 'IMN Study'}}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital of Hvidovre', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'overallOfficials': [{'name': 'Nikolaj Erin-Madsen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Copenhagen University Hospital of Hvidovre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan of sharing data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nikolaj Erin-Madsen', 'investigatorAffiliation': 'Copenhagen University Hospital, Hvidovre'}}}}