Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT05587569
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2022-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070592', 'term': 'Metatarsus Varus'}, {'id': 'D006215', 'term': 'Hallux Valgus'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiographic recurrence of hallux valgus deformity with metatarsus adductus will be evaluated at 24 months for subjects wtih successful correction', 'timeFrame': '24 Months', 'description': 'Successful correction is defined as two of the following three criteria: measured IMA \\<9.0°, HVA \\<15.0°, and TSP as ≤3 at 6 months post Adductoplasty® Procedure and Lapiplasty® Procedure. Recurrence at 24 months is defined by HVA \\>15.0°.'}], 'secondaryOutcomes': [{'measure': 'Radiographic Recurrence', 'timeFrame': '24 Months', 'description': 'Radiographic recurrence of hallux valgus deformity at 24 months defined by HVA \\>20°.'}, {'measure': 'Union vs non-Union', 'timeFrame': '12 Months', 'description': 'Evaluate clinical/radiographic healing (union vs non-union). Non-union is defined as pain and lucency at the 1st, 2nd, and/or 3rd TMT joint at 12 months post- Adductoplasty® Procedure and Lapiplasty® Procedure.'}, {'measure': 'Clinical Complications', 'timeFrame': '60 Months', 'description': 'Clinical complications due to system implants the post-op instructions or health conditions that could affect other outcome measures.'}, {'measure': 'Weight-Bearing Recovery Time', 'timeFrame': '12 Months', 'description': 'Assessment of weight-bearing recovery time following the procedures. Weight-bearing will be measured in days and recorded based upon individual surgeon recovery protocol.'}, {'measure': 'Time to Weight-Bear in Boot', 'timeFrame': '6 Weeks', 'description': 'Time to start of weight-bearing in boot, in days.'}, {'measure': 'Time to Weight-Bear in Shoes', 'timeFrame': '8 Weeks', 'description': 'Time to start of weight-bearing in shoes, in days.'}, {'measure': 'Time to Return to Unrestricted Activity', 'timeFrame': '6 weeks - 6 months, post Lapiplasty® Procedure', 'description': 'Time to return to full unrestricted activity, in days.'}, {'measure': 'Change in Pain', 'timeFrame': '0-3 weeks, 6 weeks, 4 months, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, in comparison to baseline visit pain.', 'description': 'Change in pain at the base of the big toe (bunion related), as well as the midfoot region for the operative foot only, assessed via the Visual Analog Scale (VAS) with 0-10 minimum and maximum values - with 0 being a better outcome and 10 being a worse outcome.'}, {'measure': 'Change in Quality of Life', 'timeFrame': '6 months, 12 months, 24 months, 36 months, 48 months and 60 months post-Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit', 'description': 'Change in Quality of Life, (PROMIS-29/PROMIS-25 and MOxFQ) defined as the total domain score measured.'}, {'measure': 'Change in Range of Motion', 'timeFrame': '12 months, 24 months, 36 months, 48 months and 60 months post- Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit', 'description': 'Change in Range of Motion - 1st MTP dorsiflexion and plantarflexion'}, {'measure': 'Change in Osseous Foot Width', 'timeFrame': '12 months and 24 months post - Adductoplasty™ Procedure and Lapiplasty® Procedure, in comparison to baseline visit', 'description': 'Change in osseous foot width - radiographically'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Metatarsus Adductus', 'Hallux Valgus', 'MTA3D'], 'conditions': ['Metatarsus Adductus', 'Hallux Valgus']}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, unblinded study to evaluate outcomes of the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure for patients in need of metatarsus adductus and hallux valgus correction.\n\nUp to 80 subjects will be treated in this study at up to 13 clinical sites. Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion and exclusion criteria defined in the study protocol.', 'detailedDescription': 'The objectives of this study are to evaluate outcomes of the Adductoplasty™ Procedure combined with the Lapiplasty® Procedure for patients in need of hallux valgus and metatarsus adductus surgery:\n\n1. To evaluate the quality of life and pain scores following the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure.\n2. To determine whether the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure, effectively corrects and maintains triplane anatomical alignment of the 1st, 2nd and 3rd metatarsals, the hallux position, the sesamoid position, and the foot width.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male and females ≥14 years old at the time of consent\n2. Closed physeal plates at the time of consent\n3. Intermetatarsal angle is ≥8.0˚; OR True IMA of \\>10°, (IMA+MTA-15=True IMA)\n4. Hallux valgus angle is ≥12.0˚\n5. Metatarsus adductus angle based on Sgarlatos method ≥15°\n6. Willing and able to adhere to post-op care instructions\n7. Capable of completing self-administered questionnaires\n8. Acceptable surgical candidate, including use of general anesthesia\n9. Female patients must be of non-childbearing potential or have a negative pregnancy test in accordance with hospital standards prior to the Index Procedure\n10. Willing and able to schedule index procedure within 3 months of consent and able to return for scheduled follow-up visits\n11. Willing and able to provide written informed consent\n12. Patient agrees to refrain from any reconstructive procedures on contralateral foot for minimum of 6 months post index procedure\n\nExclusion Criteria:\n\n1. Previous surgery for hallux valgus on operative side\n2. Previous surgeries on operative foot involving fusion of foot or ankle joints (other than hammertoe, lesser toes/digits, or posterior muscle lengthening)\n3. Moderate-severe osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd tarsometatarsal joints\n4. Severe osteoarthritis of the 1st, 2nd or 3rd tarsometatarsal joints\n5. Any deformity of the hindfoot or midfoot that represents a pathological condition that may affect the outcome of the tarsometatarsal realignment, or a condition that requires concomitant surgical correction\n6. BMI \\>40 kg/m²\n7. Current nicotine user in any form including vaping, smoking, oral ingestion or use of nicotine patch\n8. Current clinical diagnosis of diabetes or currently taking medication for treatment of diabetes\n9. Current clinical diagnosis of peripheral neuropathy\n10. Current clinical diagnosis of fibromyalgia\n11. Current clinical diagnosis of Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy (CRPS/RSD)\n12. Current uncontrolled hypothyroidism\n13. Current clinical diagnosis of chronic dependent edema\n14. Previously sensitized to titanium\n15. Currently taking oral steroids or rheumatoid biologics\n16. Currently taking immunosuppressant drugs\n17. Insufficient quantity or quality of bone to permit stabilization, conditions that inhibit healing (not including pathological fractures) and conditions causing poor blood supply such as peripheral vascular disease\n18. Active, suspected, or latent infection in the affected area\n19. Use of synthetic or allogenic bone graft substitutes\n20. Use of non-Treace products for Index Procedure\n21. Additional bone procedure needed during the index procedure to complete correction \\[first MTP fusion, calcaneal osteotomy, traditional medial eminence resection, additional metatarsal or tarsal bone osteotomy or fusion (other than Weil osteotomies)\\];\n22. Scheduled to undergo a same-day bilateral procedure\n23. Patient has previously been enrolled into this study for a contralateral procedure\n24. Scheduled for any concomitant procedure that would alter patient's ability to weight-bear post-procedure\n25. Patient is actively involved with a workman's compensation case or is currently involved in litigation\n26. Patient is currently in, or has participated in, a clinical study in the last 30 days prior to signing informed consent or is considering participation in another research protocol during this study. Exceptions to this include survey clinical studies with no treatment or if subject is greater than 12 months post procedure in either the Treace ALIGN3D™ or Mini3D™ Study without ongoing protocol defined AE\n27. Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the patient's well-being, the soundness of this clinical study, or could interfere with provision of informed consent, completion of tests, therapy, or follow-up"}, 'identificationModule': {'nctId': 'NCT05587569', 'acronym': 'MTA3D', 'briefTitle': 'Outcomes Following Combined Adductoplasty™ and Lapiplasty® (MTA3D)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Treace Medical Concepts, Inc.'}, 'officialTitle': 'Radiographic and Patient Reported Outcomes Following Combined Adductoplasty™ and Lapiplasty® Procedures for Correction of Metatarsus Adductus and Hallux Valgus (MTA3D)', 'orgStudyIdInfo': {'id': 'CP2022-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Treatment of metatarsus adductus and hallux valgus with the Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure', 'type': 'DEVICE', 'otherNames': ['Adductoplasty™ Procedure in combination with the Lapiplasty® Procedure'], 'description': 'Patients 14 years of age or older with symptomatic metatarsus adductus and hallux valgus will be eligible to participate based on the inclusion/exclusion criteria established in the study protocol. Anticipated study duration will be 5 years post index procedure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80634', 'city': 'Greeley', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael D Vaardahl, DPM', 'role': 'CONTACT', 'email': 'michaelvaardahlDPM@ankleandfootcenters.com', 'phone': '970-351-0900'}, {'name': 'Lauren Shodrock', 'role': 'CONTACT', 'email': 'laurenshodrock@AnkleAndFootCenters.com', 'phone': '(970) 351-0900'}, {'name': 'Michael D Vaardahl, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Foot and Ankle Center of the Rockies', 'geoPoint': {'lat': 40.42331, 'lon': -104.70913}}, {'zip': '50023', 'city': 'Ankeny', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mindi Dayton, DPM', 'role': 'CONTACT', 'email': 'mdayton@footanklecenteriowa.com', 'phone': '515-639-3775'}, {'name': 'Paul Dayton, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mindi Dayton, DPM', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jesseka Kaldenberg-Leppert, DPM', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Foot and Ankle Center of Iowa', 'geoPoint': {'lat': 41.72971, 'lon': -93.60577}}, {'zip': '04096', 'city': 'Yarmouth', 'state': 'Maine', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Barry White, DPM', 'role': 'CONTACT', 'email': 'Footdocbmw@outlook.com', 'phone': '207-888-3640'}, {'name': 'Barry White, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Coastal Maine Foot and Ankle', 'geoPoint': {'lat': 43.80064, 'lon': -70.18672}}, {'zip': '65019', 'city': 'Jefferson City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jody McAleer, DPM', 'role': 'CONTACT', 'email': 'jmcaleer@jcmg.org', 'phone': '573-556-7724'}, {'name': 'Christy Kidwell', 'role': 'CONTACT', 'email': 'christy.kidwell@avacare.com', 'phone': '(573) 556-7724'}, {'name': 'Jody McAleer, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'JCMG - Jefferson City Medical Group', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'zip': '27560', 'city': 'Morrisville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jacob Carpenter', 'role': 'CONTACT', 'email': 'jacob.carpenter@duke.edu', 'phone': '919-744-8166'}, {'name': 'Jennifer Friend', 'role': 'CONTACT', 'email': 'jennifer.friend@duke.edu', 'phone': '(919) 668-4373'}, {'name': 'Cesar de Cesar Netto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mark Easley, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Duke Orthopaedics Arringdon', 'geoPoint': {'lat': 35.82348, 'lon': -78.82556}}, {'zip': '44708', 'city': 'Canton', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Chokan, DPM', 'role': 'CONTACT', 'email': 'drchokan@gmail.com', 'phone': '330-447-4400'}, {'name': 'Aaron Chokan, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio Foot and Ankle Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '44224', 'city': 'Stow', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aaron Chokan, DPM', 'role': 'CONTACT', 'email': 'drchokan@gmail.com', 'phone': '330-929-3331'}, {'name': 'Aaron Chokan, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio Foot and Ankle Center', 'geoPoint': {'lat': 41.1595, 'lon': -81.44039}}, {'zip': '15090', 'city': 'Wexford', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William DeCarbo, DPM', 'role': 'CONTACT', 'email': 'wdecarbo@yahoo.com', 'phone': '724-799-8727'}, {'name': 'Shannon Litton', 'role': 'CONTACT', 'email': 'slitton@gpfootankle.com', 'phone': '(724) 799-8727'}, {'name': 'William DeCarbo, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Greater Pittsburgh Foot and Ankle Center', 'geoPoint': {'lat': 40.62646, 'lon': -80.05589}}, {'zip': '76248', 'city': 'Keller', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul Steinke, DPM', 'role': 'CONTACT', 'email': 'steinke@faant.com', 'phone': '817-416-6155'}, {'name': 'Paul Steinke, DPM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Foot and Ankle Associates of North Texas - Keller', 'geoPoint': {'lat': 32.93457, 'lon': -97.25168}}], 'centralContacts': [{'name': 'Cara Bethell', 'role': 'CONTACT', 'email': 'cbethell@treace.net', 'phone': '(904) 373-5940', 'phoneExt': '1317'}, {'name': 'Shana Zink', 'role': 'CONTACT', 'email': 'szink@treace.net', 'phone': '(513) 265-0621'}], 'overallOfficials': [{'name': 'Paul Dayton, DPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foot and Ankle Center of Iowa'}, {'name': 'Mark Easley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Treace Medical Concepts, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}