Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-25 @ 4:12 PM
Study NCT ID:
NCT06193057
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2023-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Customized and Standard Total Ankle Prostheses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058737', 'term': 'Arthroplasty, Replacement, Ankle'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2023-12-21', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ankle radiographic angles', 'timeFrame': 'at baseline (day 0)', 'description': 'Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.'}, {'measure': 'Ankle radiographic angles', 'timeFrame': '3 months', 'description': 'Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.'}, {'measure': 'Ankle radiographic angles', 'timeFrame': '6 months', 'description': 'Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.'}, {'measure': 'Ankle radiographic angles', 'timeFrame': '12 months', 'description': 'Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.'}, {'measure': 'Ankle radiographic angles', 'timeFrame': '18 months', 'description': 'Patients will be evaluated by how many degrees the postoperative ankle angle in loading, either varo-valgus (frontal alignment) or dorsi-plantar differs from the corresponding physiological angles (4° and 0°, respectively) when implanting a customized primary TAR (PERSONALIZED group) versus a standard primary TAR (STANDARD group) according to normal surgical practice.'}], 'secondaryOutcomes': [{'measure': 'Short form 12', 'timeFrame': 'at baseline (day 0)', 'description': 'The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."'}, {'measure': 'Short form 12', 'timeFrame': '3 months', 'description': 'The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."'}, {'measure': 'Short form 12', 'timeFrame': '6 months', 'description': 'The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."'}, {'measure': 'Short form 12', 'timeFrame': '12 months', 'description': 'The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."'}, {'measure': 'Short form 12', 'timeFrame': '18 months', 'description': 'The SF-12 health questionnaire is a generic standardized instrument for fast, economic and disease-border acquisition of health-related quality of life."'}, {'measure': 'Visual Analogic Scale', 'timeFrame': 'at baseline (day 0)', 'description': 'Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.'}, {'measure': 'Visual Analogic Scale', 'timeFrame': '3 months', 'description': 'Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.'}, {'measure': 'Visual Analogic Scale', 'timeFrame': '6 months', 'description': 'Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.'}, {'measure': 'Visual Analogic Scale', 'timeFrame': '12 months', 'description': 'Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.'}, {'measure': 'Visual Analogic Scale', 'timeFrame': '18 months', 'description': 'Visual Analogue Scale (VAS) is a measurement instrument that measures a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured; operationally a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end, where the patient marks on the line the point that they feel represents their perception of their current state. The VAS score is determined then by measuring in millimetres from the left hand end of the line to the point that the patient marks.'}, {'measure': 'American Orthopedic Foot and Ankle Score', 'timeFrame': 'at baseline (day 0)', 'description': 'This Score, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.'}, {'measure': 'American Orthopedic Foot and Ankle Score', 'timeFrame': '3 months', 'description': 'The AOFAS, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.'}, {'measure': 'American Orthopedic Foot and Ankle Score', 'timeFrame': '6 months', 'description': 'The AOFAS, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.'}, {'measure': 'American Orthopedic Foot and Ankle Score', 'timeFrame': '12 months', 'description': 'The AOFAS, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.'}, {'measure': 'American Orthopedic Foot and Ankle Score', 'timeFrame': '18 months', 'description': 'The AOFAS, based on a questionnaire, consists of points given to nine items divided in three categories: pain (40 points), functional aspects (50 points) and alignment (10 points) totaling 100 points, the extreme which represent a normal foot and ankle complex.'}, {'measure': 'Ankle Range of motion', 'timeFrame': 'at baseline (day 0)', 'description': 'Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.'}, {'measure': 'Ankle Range of motion', 'timeFrame': '3 months', 'description': 'Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.'}, {'measure': 'Ankle Range of motion', 'timeFrame': '6 months', 'description': 'Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.'}, {'measure': 'Ankle Range of motion', 'timeFrame': '12 months', 'description': 'Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.'}, {'measure': 'Ankle Range of motion', 'timeFrame': '18 months', 'description': 'Degrees of active and passive joint excursion of the ankle in dorsiflexion and plantarflexion. Normal ankle dorsiflexion is about 20°-30°, while normal plantarflexion is about 30°-50°.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['replacement', 'customized', 'TAR', 'arthroplasty', 'radiographic angles', 'clinical scores'], 'conditions': ['Ankle Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '31466570', 'type': 'RESULT', 'citation': 'Shane A, Sahli H. Total Ankle Replacement Options. Clin Podiatr Med Surg. 2019 Oct;36(4):597-607. doi: 10.1016/j.cpm.2019.06.005.'}, {'pmid': '34244049', 'type': 'RESULT', 'citation': 'Foran IM, Vafek EC, Bohl DD, Lee S, Hamid KS. Quality Assessment of Modern Total Ankle Arthroplasty Clinical Outcomes Research. J Foot Ankle Surg. 2022 Jan-Feb;61(1):7-11. doi: 10.1053/j.jfas.2021.05.011. Epub 2021 Jun 10.'}, {'pmid': '34071032', 'type': 'RESULT', 'citation': 'Mosca M, Caravelli S, Vocale E, Massimi S, Censoni D, Di Ponte M, Fuiano M, Zaffagnini S. Clinical Radiographical Outcomes and Complications after a Brand-New Total Ankle Replacement Design through an Anterior Approach: A Retrospective at a Short-Term Follow Up. J Clin Med. 2021 May 23;10(11):2258. doi: 10.3390/jcm10112258.'}, {'pmid': '25434867', 'type': 'RESULT', 'citation': 'Malerba F, Benedetti MG, Usuelli FG, Milani R, Berti L, Champlon C, Leardini A. Functional and clinical assessment of two ankle arthrodesis techniques. J Foot Ankle Surg. 2015 May-Jun;54(3):399-405. doi: 10.1053/j.jfas.2014.09.007. Epub 2014 Nov 26.'}, {'pmid': '36375147', 'type': 'RESULT', 'citation': "Goldberg AJ, Chowdhury K, Bordea E, Hauptmannova I, Blackstone J, Brooking D, Deane EL, Bendall S, Bing A, Blundell C, Dhar S, Molloy A, Milner S, Karski M, Hepple S, Siddique M, Loveday DT, Mishra V, Cooke P, Halliwell P, Townshend D, Skene SS, Dore CJ; TARVA Study Group; Brown R, Butler M, Chadwick C, Clough T, Cullen N, Davies M, Davies H, Harries B, Khoo M, Makwana N, Murty A, Najefi A, O'Donnell P, Raglan M, Thomas R, Torres P, Welck M, Winson I, Zaidi R. Total Ankle Replacement Versus Arthrodesis for End-Stage Ankle Osteoarthritis: A Randomized Controlled Trial. Ann Intern Med. 2022 Dec;175(12):1648-1657. doi: 10.7326/M22-2058. Epub 2022 Nov 15."}, {'pmid': '30537247', 'type': 'RESULT', 'citation': 'Belvedere C, Siegler S, Fortunato A, Caravaggi P, Liverani E, Durante S, Ensini A, Konow T, Leardini A. New comprehensive procedure for custom-made total ankle replacements: Medical imaging, joint modeling, prosthesis design, and 3D printing. J Orthop Res. 2019 Mar;37(3):760-768. doi: 10.1002/jor.24198. Epub 2019 Jan 3.'}, {'pmid': '32876778', 'type': 'RESULT', 'citation': 'Faldini C, Mazzotti A, Belvedere C, Durastanti G, Panciera A, Geraci G, Leardini A. A new ligament-compatible patient-specific 3D-printed implant and instrumentation for total ankle arthroplasty: from biomechanical studies to clinical cases. J Orthop Traumatol. 2020 Sep 2;21(1):16. doi: 10.1186/s10195-020-00555-7.'}, {'pmid': '35317257', 'type': 'RESULT', 'citation': 'Mazzotti A, Arceri A, Zielli S, Bonelli S, Viglione V, Faldini C. Patient-specific instrumentation in total ankle arthroplasty. World J Orthop. 2022 Mar 18;13(3):230-237. doi: 10.5312/wjo.v13.i3.230. eCollection 2022 Mar 18.'}, {'pmid': '34652517', 'type': 'RESULT', 'citation': 'Brinkmann EJ, Fitz W. Custom total knee: understanding the indication and process. Arch Orthop Trauma Surg. 2021 Dec;141(12):2205-2216. doi: 10.1007/s00402-021-04172-9. Epub 2021 Oct 15.'}, {'pmid': '36935170', 'type': 'RESULT', 'citation': 'Leardini A, Belvedere C, de Cesar Netto C. Total Ankle Replacement: Biomechanics of the Designs, Clinical Outcomes, and Remaining Issues. Foot Ankle Clin. 2023 Mar;28(1S):e1-e14. doi: 10.1016/j.fcl.2023.01.001. Epub 2023 Mar 1.'}, {'pmid': '34560346', 'type': 'RESULT', 'citation': 'Ferraro D, Siegler S, Belvedere C, Ruiz M, Leardini A. Effect of artificial surface shapes and their malpositioning on the mechanics of the replaced ankle joint for possible better prosthesis designs. Clin Biomech (Bristol). 2021 Dec;90:105489. doi: 10.1016/j.clinbiomech.2021.105489. Epub 2021 Sep 17.'}, {'pmid': '36207422', 'type': 'RESULT', 'citation': 'Pavani C, Belvedere C, Ortolani M, Girolami M, Durante S, Berti L, Leardini A. 3D measurement techniques for the hindfoot alignment angle from weight-bearing CT in a clinical population. Sci Rep. 2022 Oct 7;12(1):16900. doi: 10.1038/s41598-022-21440-9.'}, {'pmid': '7951968', 'type': 'RESULT', 'citation': 'Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. doi: 10.1177/107110079401500701.'}, {'pmid': '2780060', 'type': 'RESULT', 'citation': 'Boeckstyns MEH, Backer M. Reliability and validity of the evaluation of pain in patients with total knee replacement. Pain. 1989 Jul;38(1):29-33. doi: 10.1016/0304-3959(89)90069-9.'}, {'pmid': '28732149', 'type': 'RESULT', 'citation': 'Hagell P, Westergren A, Arestedt K. Beware of the origin of numbers: Standard scoring of the SF-12 and SF-36 summary measures distorts measurement and score interpretations. Res Nurs Health. 2017 Aug;40(4):378-386. doi: 10.1002/nur.21806.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare primary total ankle replacement (TAR) performed with a customized procedure (prostheses customized for each patient based on his or her ankle morphology reconstructed from tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TARs, considering: objective radiological results, subjective patient outcomes, and overall costs of both procedures'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who are candidates for primary total ankle replacement.\n* Consenting patients and able to complete scheduled study procedures and follow-up evaluations.\n* Patients who have signed the "informed consent" approved by the Ethics Committee.\n\nExclusion Criteria:\n\n* Social conditions (homeless patients, with restrictions on personal freedom)\n* ASA 3 and 4\n* Deep venous insufficiency Lower limbs\n* History of Erisipelas lower limbs\n* Neurological or psychocognitive disorders\n* neurological diseases\n* Axial deformities of ankle \\>15°\n* Personal or family history of DVT or EP\n* Prosthetic and/or arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis)\n* Pregnant women\n* Patients with rheumatic diseases\n* Patients that requires ancillary surgical procedures'}, 'identificationModule': {'nctId': 'NCT06193057', 'briefTitle': 'Comparison of Customized and Standard Total Ankle Prostheses', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study', 'orgStudyIdInfo': {'id': '3POD-TAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional', 'description': 'In the STANDARD group, patients will undergo a primary TAR by implanting a prosthetic model of a standard design, that is the same for all using the usual surgical technique and instrumentation (based on the use of external leg guidance)', 'interventionNames': ['Procedure: Total ankle arthroplasty']}, {'type': 'EXPERIMENTAL', 'label': 'Custom', 'description': "In the PERSONALIZED group, patients will undergo a primary TAR by implanting a prosthetic model with a design specifically based on each patient's actual ankle morphology and using PSI surgical technique and instrumentation.", 'interventionNames': ['Procedure: Total ankle arthroplasty']}], 'interventions': [{'name': 'Total ankle arthroplasty', 'type': 'PROCEDURE', 'otherNames': ['Total ankle arthroplasty with anterior approach'], 'description': "Patients who underwent ankle prosthesis implantation procedure with an anterior approach were involved in a longitudinal skin incision of about 12-15cm anterior to the tibio-tarsal joint in supine position. Once the deep layers were reached, passing through the anterior tibial tendon and extensor hallucis longus tendon sheath, the tibio-tarsal joint was then exposed. The operator proceeds to astragalic and tibial resections, once the appropriate size of implants was selected, the final components were implanted. In both groups, the basic prosthetic design approach will be 'three-component,' that is, with congruent mobile meniscus interposed between the tibial and astragalic components. At the end of the procedure, orthopedic walker boot was placed for 3 weeks, and progressive weight allowed.", 'armGroupLabels': ['Custom', 'Traditional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40126', 'city': 'Bologna', 'state': 'BO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimiliano Mosca', 'role': 'CONTACT', 'email': 'massimiliano.mosca@ior.it', 'phone': '0516366080'}], 'facility': 'Rizzoli Orthopaedic Institute', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'massimiliano mosca, MD', 'role': 'CONTACT', 'email': 'massimiliano.mosca@ior.it', 'phone': '0516366', 'phoneExt': '162'}, {'name': 'silvio caravelli, MD', 'role': 'CONTACT', 'email': 'silvio.caravelli@ior.it', 'phone': '0516366', 'phoneExt': '084'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}