Knee Osteotomy Associated With Allograft Meniscus Transplantation
NCT ID: NCT05840887
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
52 participants
INTERVENTIONAL
2023-08-30
2026-06-30
Brief Summary
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The main objective of the BIOMAT project is to demonstrate, through an RCT, whether the combined approach by knee osteotomy and MAT can provide clinical improvement over knee osteotomy alone for the treatment of patients with monocompartmental knee OA associated with meniscal insufficiency and lower extremity malalignment. Secondary objectives are to demonstrate whether the addition of MAT to knee osteotomy in patients with monocompartmental OA can improve biomechanical parameters and whether this treatment has protective effects on the joint environment and cartilage degeneration.
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Detailed Description
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Enrollment takes place during hospitalization and is by the physician. All patients will undergo a knee osteotomy to achieve proper alignment of the lower limb and an arthroscopic procedure to macroscopically verify the status of the cartilage and menisci, with associated minor procedures for surgical cleanup when necessary. After intraoperative confirmation of inclusion criteria (complete meniscal deficit and absence of severe articular cartilage impairment) all patients will undergo synovial biopsy and synovial fluid sampling, half of the patients will also undergo arthroscopic homologous meniscus transplantation.
Clinical, biomechanical and biological evaluations will be performed:
Clinical evaluation of the patient will be done through validated questionnaires before surgery and at 1-3-6-12 months. These will document subjective clinical improvement, functional measurements, and imaging using radiographs as per clinical practice and MRI.
Pitch Analysis will be used for biomechanical assessments, and will be performed before surgery and at 12-month follow-up after surgery for all patients enrolled in the two groups.
basal inflammation will be assessed on synovial tissue and synovial fluid samples collected after intraoperative confirmation of patient inclusion criteria (complete meniscal deficit and absence of severe articular cartilage impairment). Serum/plasma and urine samples will be collected before surgical treatment and at 1-3-6-12 months follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Knee Ostetomy combined with meniscal allograft transplantation
The treatment group will perform osteotomy and meniscal allograft transplantation to restore the meniscal deficiency.
Knee osteotomy associated with meniscal allograft transplantation
Patients will undergo knee osteotomy associated with meniscal allograft transplantation, which will be implanted by arthroscopic technique with body fixation by all-inside and transosseous sutures to the posterior horn and if necessary to the anterior horn.
Knee Osteotomy
The control group will consist of patients who will perform an isolated osteotomy.
Knee osteotomy
Knee osteotomy
Interventions
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Knee osteotomy associated with meniscal allograft transplantation
Patients will undergo knee osteotomy associated with meniscal allograft transplantation, which will be implanted by arthroscopic technique with body fixation by all-inside and transosseous sutures to the posterior horn and if necessary to the anterior horn.
Knee osteotomy
Knee osteotomy
Eligibility Criteria
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Inclusion Criteria
2. Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≤ 3);
3. Surgical indication of corrective osteotomy (axial deviation of lower extremities \> 5°);
4. Meniscal deficit of the compartment affected by the overload due to malalignment;
5. Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up (RX and MRI)
6. Signature of informed consent
Exclusion Criteria
2. Diagnosis of neoplastic diseases;
3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; human immunodeficiency virus (HIV) infection, viral hepatitis; chondrocalcinosis;
4. Patients with uncontrolled diabetes mellitus;
5. Patients with uncontrolled thyroid metabolic disorders;
6. Patients abusing alcoholic beverages, drugs or medications;
7. Body Mass Index \> 40;
8. Pregnancy or lactation status or intention to become pregnant during the period of study participation;
9. Patients undergoing knee surgery in the previous 12 months.
20 Years
60 Years
ALL
No
Sponsors
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Istituto Ortopedico Rizzoli
OTHER
Responsible Party
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Locations
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Istituto Ortopedico Rizzoli
Bologna, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Murray R, Winkler PW, Shaikh HS, Musahl V. High Tibial Osteotomy for Varus Deformity of the Knee. J Am Acad Orthop Surg Glob Res Rev. 2021 Jul 9;5(7):e21.00141. doi: 10.5435/JAAOSGlobal-D-21-00141.
Nicolini AP, Christiano ES, Abdalla RJ, Cohen M, de Carvalho RT. Return to Sports After High Tibial Osteotomy Using the Opening Wedge Technique. Rev Bras Ortop (Sao Paulo). 2021 Jun;56(3):313-319. doi: 10.1055/s-0040-1715514. Epub 2020 Sep 25.
McClure PK, Herzenberg JE. The Natural History of Lower Extremity Malalignment. J Pediatr Orthop. 2019 Jul;39(Issue 6, Supplement 1 Suppl 1):S14-S19. doi: 10.1097/BPO.0000000000001361.
Smoak JB, Matthews JR, Vinod AV, Kluczynski MA, Bisson LJ. An Up-to-Date Review of the Meniscus Literature: A Systematic Summary of Systematic Reviews and Meta-analyses. Orthop J Sports Med. 2020 Sep 9;8(9):2325967120950306. doi: 10.1177/2325967120950306. eCollection 2020 Sep.
Liu JN, Agarwalla A, Gomoll AH. High Tibial Osteotomy and Medial Meniscus Transplant. Clin Sports Med. 2019 Jul;38(3):401-416. doi: 10.1016/j.csm.2019.02.006.
Wang K, Sun H, Zhang K, Li S, Wu G, Zhou J, Sun X. Better outcomes are associated with cementless fixation in primary total knee arthroplasty in young patients: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2020 Jan;99(3):e18750. doi: 10.1097/MD.0000000000018750.
Sheng P, Lehto M, Kataja M, Halonen P, Moilanen T, Pajamaki J. Patient outcome following revision total knee arthroplasty: a meta-analysis. Int Orthop. 2004 Apr;28(2):78-81. doi: 10.1007/s00264-003-0526-x. Epub 2003 Nov 20.
Huizinga MR, Gorter J, Demmer A, Bierma-Zeinstra SMA, Brouwer RW. Progression of medial compartmental osteoarthritis 2-8 years after lateral closing-wedge high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2017 Dec;25(12):3679-3686. doi: 10.1007/s00167-016-4232-9. Epub 2016 Jul 7.
Ekhtiari S, Haldane CE, de Sa D, Simunovic N, Musahl V, Ayeni OR. Return to Work and Sport Following High Tibial Osteotomy: A Systematic Review. J Bone Joint Surg Am. 2016 Sep 21;98(18):1568-77. doi: 10.2106/JBJS.16.00036.
Berruto M, Maione A, Tradati D, Ferrua P, Uboldi FM, Usellini E. Closing-wedge high tibial osteotomy, a reliable procedure for osteoarthritic varus knee. Knee Surg Sports Traumatol Arthrosc. 2020 Dec;28(12):3955-3961. doi: 10.1007/s00167-020-05890-0. Epub 2020 Feb 13.
De Bruycker M, Verdonk PCM, Verdonk RC. Meniscal allograft transplantation: a meta-analysis. SICOT J. 2017;3:33. doi: 10.1051/sicotj/2017016. Epub 2017 Apr 21.
Zaffagnini S, Grassi A, Marcheggiani Muccioli GM, Benzi A, Serra M, Rotini M, Bragonzoni L, Marcacci M. Survivorship and clinical outcomes of 147 consecutive isolated or combined arthroscopic bone plug free meniscal allograft transplantation. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1432-9. doi: 10.1007/s00167-016-4035-z. Epub 2016 Feb 9.
Zaffagnini S, Grassi A, Macchiarola L, Stefanelli F, Coco V, Marcacci M, Andriolo L, Filardo G. Meniscal Allograft Transplantation Is an Effective Treatment in Patients Older Than 50 Years but Yields Inferior Results Compared With Younger Patients: A Case-Control Study. Arthroscopy. 2019 Aug;35(8):2448-2458. doi: 10.1016/j.arthro.2019.03.048.
Zaffagnini S, Di Paolo S, Stefanelli F, Dal Fabbro G, Macchiarola L, Lucidi GA, Grassi A. The biomechanical role of meniscal allograft transplantation and preliminary in-vivo kinematic evaluation. J Exp Orthop. 2019 Jun 25;6(1):27. doi: 10.1186/s40634-019-0196-2.
Marcacci M, Zaffagnini S, Kon E, Marcheggiani Muccioli GM, Di Martino A, Di Matteo B, Bonanzinga T, Iacono F, Filardo G. Unicompartmental osteoarthritis: an integrated biomechanical and biological approach as alternative to metal resurfacing. Knee Surg Sports Traumatol Arthrosc. 2013 Nov;21(11):2509-17. doi: 10.1007/s00167-013-2388-0. Epub 2013 Jan 31.
Zanasi L, Boffa A, De Marziani L, Lisignoli G, Belvedere C, Miceli M, Zaffagnini S, Filardo G, Di Martino A. Knee osteotomy combined with meniscal allograft transplantation versus knee osteotomy alone in patients with unicompartmental knee osteoarthritis: a prospective double-blind randomised controlled trial protocol. BMJ Open. 2024 Dec 12;14(12):e087552. doi: 10.1136/bmjopen-2024-087552.
Other Identifiers
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BIOMAT
Identifier Type: -
Identifier Source: org_study_id
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