ABSTRACT Objective Phase 1 clinical trial to determine feasibility, safety, and efficacy of a new advanced cell therapy product for treatment of knee articular cartilage injuries. Methods Three participants with knee focal chondral lesions were included, with no signs of osteoarthritis. Chondrocytes were obtained through knee arthroscopy, cultured in collagen membrane for 3 weeks at the laboratory, subjected to tests to release the cell therapy product, and implanted. All patients underwent a specific 3-month rehabilitation protocol, followed by assessments using functional and imaging scales. The main outcome was the incidence of severe adverse events. Results Three participants were included and completed the 2-year follow-up. There was one severe adverse event, venous thrombosis of distal leg veins, which was no associated with therapy, was treated and left no sequelae. The clinical and radiological scales showed improvement in the three cases. Conclusion The preliminary results, obtained with the described methodology, allow concluding that this product of advanced cell therapy is safe and feasible. ReBEC platform registration number: RBR-6fgy76

ABSTRACT To describe a case of autologous chondrocyte implantation after cell culture contamination by Mycoplasma pneumoniae and the measures taken to successfully complete cell therapy in a patient with focal chondral lesion. A 45-year-old male patient, complaining of chronic pain on the knee and no history of trauma. He had a chondral lesion in the trochlear region of the femur and clinical tests compatible with pain in the anterior compartment of the knee. Conservative treatment failed to alleviate symptoms. Surgical treatment was indicated, but due to the size of the lesion, membrane-assisted autologous chondrocyte implantation was the technique of choice. Cartilage biopsies were collected from the intercondylar region of the distal femur. After isolation, chondrocytes were expanded ex vivo in a trained laboratory, for three weeks, and seeded onto a commercially available collagen membrane prior to implantation in the knee. Two days before surgery, a cell culture sample tested positive for Mycoplasma pneumoniae. The source of contamination was found to be autologous blood serum, extracted from the patient´s peripheral vein, and used to supplement the cell culture medium. After treating the patient with antibiotics, all procedures were repeated and the new final cell product, free from contaminants, was successfully implanted. We discuss the strategies available to deal with this situation, and describe the results of this particular case, which led to modifications in the autologous chondrocyte implant protocol.

OBJECTIVE: This study aimed to develop a new histological scoring system for use in a partial-thickness cartilage repair animal model. Although previous papers have investigated the regeneration of articular cartilage, the good results achieved in small animals have not been replicated in large animal models or humans, possibly because of the frequent use of models with perforation of the subchondral bone plates. Partial-thickness lesions spare the subchondral bone, and this pattern is the most frequent in humans; therefore, new therapies should be tested using this model. However, no specific histological score exists to evaluate partial-thickness model results. METHODS: Histological sections from 30 ovine knees were reviewed to develop a new scoring system. The sections were subjected to H&E, Safranin O, and Masson’s trichrome staining. RESULTS: This paper describes a new scoring tool that is divided into sections in detail: repair of tissue inside the lesion, cartilage around the lesion and degenerative changes at the base of the lesion. Scores range from 0 to 21; a higher score indicates better cartilage repair. DISCUSSION: Unlike existing tools, this new scale does not assign points for the positioning of a tidemark; we propose evaluation of the degenerative changes to the subchondral bone and calcified cartilage layer. It is necessary to remove the whole joint to access and study the evolution of the lesion as well as the surrounding tissue. CONCLUSION: This article emphasizes the importance of a partial-thickness animal model of cartilage repair and presents a new histological scoring system.

RESUMO Objetivos: Avaliar a hipótese de que o enxerto ósseo autólogo da crista ilíaca não melhora o resultado clínico e não diminui a incidência de complicações em pacientes submetidos à osteotomia de Puddu. Métodos: Foram avaliados 40 pacientes alocados de forma aleatória em dois grupos em um estudo clínico duplo cego entre 2007 e 2010. Um grupo recebeu enxerto ósseo e o outro grupo foi deixado sem preenchimento da osteotomia. O desfecho primário foi a escala clínica daKnee Society(KSS). A medida radiográfica do ângulo anatômico entre o fêmur e a tíbia no plano frontal e a progressão da osteoartrite de acordo com a classificação modificada de Ahlback foram usadas como desfechos secundários. Resultados: Não houve diferença da escala KSS no grupo com enxerto (64,4 ± 21,8) e no grupo sem enxerto (61,6 ± 17,3; p = 0,309). Não houve diferença do ângulo entre o fêmur e a tíbia no plano frontal entre os grupos (com enxerto = 184 ± 4,6 graus; sem enxerto = 183,4 ± 5,1 graus; p = 1,0), indica que não há uma perda de correção pela falta do enxerto. Houve pioria da osteoartrite em um número maior de pacientes no grupo com enxerto (p = 0,005). Conclusão: O enxerto ósseo autólogo da crista ilíaca não melhorou o resultado clínico e não diminuiu a incidência de complicações em pacientes submetidos à osteotomia de Puddu, fixadas com placa-calço de primeira geração, nas condições deste estudo.

ABSTRACT Objectives: To test the hypothesis that autologous iliac bone grafts do not enhance clinical results and do not decrease complication rates in patients undergoing medial opening-wedge high tibial , osteotomy. Methods: Forty patients allocated in a randomized, two-armed, double-blinded clinical trial were evaluated between 2007 and 2010. One group received bone graft, and the other group was left without filling the osteotomy defect. The primary outcome was the Knee Society Score. , Radiographic measurement of the frontal anatomical femoral-tibial angle and the progression of osteoarthritis according to the modified Ahlback classification were used as secondary outcomes., Results: There was no difference in KSS scale between the graft group (64.4 ± 21.8) and the graftless group (61.6 ± 17.3; p= 0.309). There was no difference of angle between the femur and tibia in the frontal plane between the groups (graft, = 184 ± 4.6 degrees, graftless = 183.4 ± 5.1 degrees; p= 1.0), indicating that there is no loss of correction due to the lack of the graft. There was significant aggravation of osteoarthritis in a greater number of patients in a graft group (p= 0.005) . Conclusion: Autologous iliac bone graft does not improve clinical outcomes in medium and long-term follow-up of medial opening-wedge high tibial osteotomy fixed with a first generation Puddu plate in the conditions of this study.

RESUMO OBJETIVO: Comparar os resultados clínicos e radiológicos da via de acesso convencional com artrotomia medial e da via de acesso lateral na prótese total primária em joelho valgo. MÉTODOS: Neste ensaio clínico prospectivo, 21 pacientes com osteoartrite e deformidade em valgo foram divididos aleatoriamente em dois grupos de acordo com a via de acesso cirúrgico usada: medial ou lateral. O desfecho principal foi a medida radiográfica da inclinação lateral da patela. Outros desfechos foram a dor após a cirurgia (escala visual de dor), o sangramento (níveis séricos de hemoglobina) e o aspecto clínico da ferida operatória. RESULTADOS: Não houve diferença entre os grupos em relação a outras variáveis clínicas. A inclinação lateral média da patela no grupo lateral foi 3,1 graus ± 5,3 DP e no grupo medial foi 18 graus ± 10,2 DP (p = 0,02). Os outros desfechos não apresentaram diferenças entre os grupos. CONCLUSÃO: A via lateral proveu melhor inclinação lateral da patela pós-operatória nas artroplastias do joelho valgo.

ABSTRACT OBJECTIVE: To compare the clinical and radiological outcomes of conventional medial and lateral approaches for total knee replacement in the valgus osteoarthritic knee. METHODS: In this randomized controlled trial, 21 patients with valgus knee osteoarthritis were randomized to total knee replacement through medial or lateral approach. The primary outcome was radiographic patellar tilt. Secondary outcomes were visual analog scale of pain, postoperative levels of hemoglobin, and clinical aspect of the operative wound. RESULTS: There were no differences between the groups regarding other clinical variables. Mean lateral tilt of the patella was 3.1 degrees (SD ± 5.3) in the lateral approach group and 18 degrees (SD ± 10.2) in the medial approach group (p = 0.02). There were no differences regarding the secondary outcomes. CONCLUSION: Lateral approach provided better patellar tilt following total knee replacement in valgus osteoarthritic knee.

OBJETIVO: Demonstrar a presença e magnitude de determinadas variáveis biomecânicas na marcha de pacientes com osteoartrite (OA) medial de joelho e suas relações com o carregamento deste. MÉTODOS: Vinte e um indivíduos diagnosticados com OA do compartimento medial do joelho foram submetidos à avaliação da marcha e comparados com grupo controle. RESULTADOS: O grupo com OA em relação ao grupo controle apresentou: menor velocidade da marcha (0,8±0,1 vs. 1,1±0,1m/s), maior pico precoce do momento adutor (2,6±1,2 vs. 0,3±1,4 Nm/kg), maior pico tardio do momento adutor (1,8±0,7 vs. 0,9±0,2 Nm/kg), maior pico do momento flexor (1,6±0,9 vs. 0,6±0,4 Nm/kg), elevado pico de varo dinâmico (11,5º±8,3 vs. 3º±3,9), maior pico de flexão (15,6º±8 vs. 9,3º±4,1), com tendência ao flexo (5,5º±8,5) na fase de apoio, menor pico de flexão (58,7º±13,3 vs. 67,5º±4,8) no balanço e elevados picos de rotação externa (25,5º±12,7 vs. 0,5º±12,4). Os picos de ângulos e de momentos ocorreram nas mesmas fases da marcha nos dois grupos. CONCLUSÃO: Pacientes com OA do compartimento medial do joelho apresentam modificações na marcha com aumento rotação externa, redução da velocidade, aumento do momento flexor e flexão no apoio, insuficientes para uma redução considerável do carregamento. Nível de Evidência III, Estudo caso-controle.

OBJETIVE: Demonstrate the presence and magnitude of biomechanical variables during gait in patients with medial knee osteoarthritis (OA) and the relationship with the knee loading. METHODS: Gait of 21 subjects diagnosed with medial knee OA was evaluated and compared to the control group. RESULTS: The group with OA showed: Lower gait speed (0.8 ± 0.1 vs. 1.1 ± 0.1m/s), higher peak early (2.6 ± 1.2 vs. 0.3 ± 1.4 Nm/Kg) and late peak of the adduction moment (1.8 ± 0.7 vs. 0.9 ± 0.2 Nm/Kg), higher peak flexor moment (1.6 ± 0.9 vs. 0.6 ± 0.4 Nm/Kg) , high dynamic peak varus (11.5 ± 8.3 vs. 3o ± 3.9), higher peak flexion (15.6o ± 8 vs. 9.3o to ± 4.1), with a flexion tendency (5.5 o ± 8.5) in the stance phase, smaller peak of flexion (58.7o ± 13.3 vs. 67.5 o ± 4.8) in the balance phase and and higher peaks of external rotation (25.5o ± 12.7 vs. 0.5o ± 22.4). CONCLUSION: Patients with medial knee OA show changes in gait with increased external rotation, speed reduction, increased flexor moment and flexion in the stance phase, insufficient for reduction of the load. Level of Evidence III, Case Control Study.