Knee Osteotomy Associated With Allograft Meniscus Transplantation

NCT05840887 | Recruiting

• 1 other identifier: BIOMAT
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized double-blind controlled clinical trial with parallel arms and 1:1 allocation. 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.

Conditions

Malalignment, Bone; Osteoarthritis, Knee

Keywords

knee osteotomy; MAT; meniscal allograft transplatation

Outcome Measures

Primary Outcomes (1)

• IKDC-Subjective Score (Subjective International Knee Documentation Committee)

  This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function

  12 months follow-up

Secondary Outcomes (11)

• IKDC-Subjective Score (Subjective International Knee Documentation Committee)

  baseline, 1 month, 3 months and 6months follow-up

• WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score

  baseline, 1 month, 3 months, 6 months and 12 months follow-up

• KOOS Score ( Knee Injury and Osteoarthritis Outcome score)

  baseline, 1 month, 3 months, 6 and 12 months follow-up

• VAS-dolore (Visual Analogue Scale)

  baseline, 1 month, 3 months, 6 and 12 months follow-up

• EQ-VAS

  baseline, 1 month, 3 months, 6 and 12 months follow-up

Study Arms (2)

Knee Ostetomy combined with meniscal allograft transplantation

EXPERIMENTAL

The treatment group will perform osteotomy and meniscal allograft transplantation to restore the meniscal deficiency.

Procedure: Knee osteotomy associated with meniscal allograft transplantation

Knee Osteotomy

ACTIVE COMPARATOR

The control group will consist of patients who will perform an isolated osteotomy.

Procedure: Knee osteotomy

Interventions

Knee osteotomy PROCEDURE

Knee osteotomy

Knee Osteotomy

Knee osteotomy associated with meniscal allograft transplantation PROCEDURE

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 Ostetomy combined with meniscal allograft transplantation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patients aged between 20 and 60 years;
• Single-compartment tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≤ 3);
• Surgical indication of corrective osteotomy (axial deviation of lower extremities \> 5°);
• Meniscal deficit of the compartment affected by the overload due to malalignment;
• Ability and consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up (RX and MRI)
• Signature of informed consent

You may not qualify if:

• Patients who are incapacitated or have neurological disorders that may invalidate the research protocol;
• Diagnosis of neoplastic diseases;
• 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;
• Patients with uncontrolled diabetes mellitus;
• Patients with uncontrolled thyroid metabolic disorders;
• Patients abusing alcoholic beverages, drugs or medications;
• Body Mass Index \> 40;
• Pregnancy or lactation status or intention to become pregnant during the period of study participation;
• Patients undergoing knee surgery in the previous 12 months.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (16)

• 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.

  PMID: 34239195 BACKGROUND

• 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.

  PMID: 31169641 BACKGROUND

• 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.

  PMID: 32953923 BACKGROUND

• 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.

  PMID: 31079771 BACKGROUND

• 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.

  PMID: 32011458 BACKGROUND

• 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.

  PMID: 15224164 BACKGROUND

• 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.

  PMID: 27387307 BACKGROUND

• 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.

  PMID: 27655985 BACKGROUND

• 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.

  PMID: 34242204 BACKGROUND

• 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.

  PMID: 32055878 BACKGROUND

• 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.

  PMID: 29792399 BACKGROUND

• 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.

  PMID: 26860105 BACKGROUND

• 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.

  PMID: 31395185 BACKGROUND

• 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.

  PMID: 31240420 BACKGROUND

• 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.

  PMID: 23370980 BACKGROUND

• 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.

  PMID: 39672576 DERIVED

MeSH Terms

Conditions

Bone Malalignment; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Central Study Contacts

Alessandro Di Martino, MD

CONTACT

6366567; roberta.licciardi@ior.it

Roberta Licciardi, MSc

CONTACT

6366567; roberta.licciardi@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Clinical evaluations will be carried out by medical personnel not involved in treatment to ensure double-blinding
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 3, 2023
• Study Start: August 30, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)