Validation of a second-generation appropriateness classification system for total knee arthroplasty: a prospective cohort study.

BACKGROUND: To test the validity of a second-generation appropriateness system in a cohort of patients undergoing total knee arthroplasty (TKA). METHODS: We applied the RAND/UCLA Appropriateness Method to derive our second-generation system and conducted a prospective study of patients diagnosed with knee osteoarthritis in eight public hospitals in Spain. Main outcome questionnaires were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short-Form-12 (SF-12), and the Knee Society Score satisfaction scale (KSS), completed before and 6 months after TKA. Baseline, changes from baseline to 6 months (journey outcome), and 6-month scores (destination outcome) were compared according to appropriateness category. Percentage of patients attaining the minimal clinically important difference (MCID) and responders according to Outcome Measures in Rheumatology-Osteoarthritis Research Society (OMERACT-OARSI) criteria were also reported. RESULTS: A total of 282 patients completed baseline and 6-month questionnaires. Of these, 142 (50.4%) were classified as Appropriate, 90 (31.9%) as Uncertain, and 50 (17.7%) as Inappropriate. Patients classified as Appropriate had worse preoperative pain, function, and satisfaction (p < 0.001) and had greater improvements (i.e., journey scores) than those classified as Inappropriate (p < 0.001). At 6 months, destination scores for pain, function, or satisfaction were not significantly different across appropriateness categories. The percentage of patients meeting responder criteria (p < 0.001) and attaining MCID was statistically higher in Appropriate versus Inappropriate groups in pain (p = 0.04) and function (p = 0.004). CONCLUSIONS: The validity of our second-generation appropriateness system was generally supported. The findings highlight a critical issue in TKA healthcare: whether TKA appropriateness should be driven by the extent of improvement, by patient final state, or by both.

Severe tibial plateau fractures (Schatzker V-VI): open reduction and internal fixation versus hybrid external fixation.

Tibial plateau fractures (TPF) are highly prone to complications and adverse effects. Their treatment has long been a matter of controversy, as fracture patterns and possible damage to soft tissues can easily aggravate complications. On the one hand, open reduction and internal fixation (ORIF) techniques provide a good approach to joint shape restoration and biomechanics, but they may also provoke a higher rate of soft-tissue complications. On the other, hybrid external fixation (HEF), although allowing little facility for reduction, may, theoretically, produce much less damage to the soft tissues. We present 93 cases of TPF classified as type V or VI that were followed up for at least 24 months. There were no statistical differences among them in relation to consolidation, secondary malalignment or range of motion, according to whether ORIF or HEF was employed. However, when external fixation followed open reduction, both superficial and deep-infection rates were higher.

Allograft plus OP-1 enhances ossification in posterolateral lumbar fusion: A seven year follow-up.

PURPOSE: To study the results of the combination of allograft plus BMP-7 in comparison with allograft alone in posterolateral lumbar arthrodesis. PATIENTS AND METHODS: A blinded controlled consecutive prospective cohort of skeletally mature patients study. One hundred and ten patients underwent posterolateral lumbar instrumented arthrodesis. Allograft randomly compacted onto either the right or the left side of the articular and the posterior aspect of the transverse processes of lumbar spine. The same procedure performed on the contralateral side, but allograft was previously mixed with osteogenic protein (OP-1). Clinical, x-ray and CT-scan long follow-up performed. Univariable and multivariable logistic regression analyses. RESULTS: More bone continuity was found with allograft plus OP-1 than with allograft alone (p>0.0038). The amount of bone mass was greater on the OP-1 side (p<0.001). No local or systemic adverse effect were noted. CONCLUSIONS: Allograft on one side plus allograft with BMP-7 on the other achieved a fusion rate of 93 per cent. Allograft combined with BMP-7 was more effective than allograft alone.

Autologous human-derived bone marrow cells exposed to a novel TGF-beta1 fusion protein for the treatment of critically sized tibial defect.

We report the first clinical case of transplantation of autologous bone marrow-derived cells in vitro exposed to a novel recombinant human transforming growth factor (rhTGF)-beta1 fusion protein bearing a collagen-binding domain (rhTGF-beta(1)-F2), dexamethasone (DEX) and beta-glycerophosphate (beta-GP). When such culture-expanded cells were loaded into porous ceramic scaffolds and transplanted into the bone defect of a 69-year-old man, they differentiated into bone tissue. Marrow cells were obtained from the iliac crest and cultured in collagen gels impregnated with rhTGF-beta1-F2. Cells were selected under serum-restricted conditions in rhTGF-beta(1)-F2-containing medium for 10 days, expanded in 20% serum for 22 days and osteoinduced for 3 additional days in DEX/beta-GP-supplemented medium. We found that the cell number harvested from rhTGF-beta(1)-F2-treated cultures was significantly higher (2.3- to 3-fold) than that from untreated cultures. rhTGF-beta(1)-F2 treatment also significantly increased alkaline phosphatase activity (2.2- to 5-fold) and osteocalcin synthesis, while calcium was only detected in rhTGF-beta(1)-F2-treated cells. Eight weeks after transplantation, most of the scaffold pores were filled with bone and marrow tissue. When we tested the same human cells treated in vitro in a rat model using diffusion chambers, there was subsequent development of cartilage and bone following the subcutaneous transplantation of rhTGF-beta(1)-F2-treated cells. This supports the suggestion that such cells were marrow-derived cells, with chondrogenic and osteogenic potential, whereas the untreated cells were not under the same conditions. The ability for differentiation into cartilage and bone tissues, combined with an extensive proliferation capacity, makes such a marrow-derived stem cell population valuable to induce bone regeneration at skeletal defect sites.