Intra-articular gold induced cytokine (GOLDIC®) injection therapy in patients with osteoarthritis of knee joint: a clinical study.

PURPOSE: To evaluate the safety and efficacy of a novel technique of preconditioning autologous blood with gold particles (GOLDIC®) and injection in patients with moderate to severe knee osteoarthritis (KOA). METHODS: During this phase 2a, proof-of-concept (PoC) open label study, 83 consecutive patients that 64 patients met inclusion criteria (mean age: 64.8 years; 89 knees) with radiographically proven KOA, received four ultrasound guided intra-articular knee injections of GOLDIC® at three to six day intervals. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS) were evaluated at baseline, four weeks, three, six months, one, two and four years (T1-T6). The incidence of treatment related severe adverse events (SAEs) recorded. Intra-articular gelsolin level in patients with effusion was determined. RESULTS: KOOS and WOMAC scores improved for the full duration of the study (P < 0.05), minimal clinically important difference (MCID) was observed at all time points in all KOOS subscores, with no reported SAEs. Intra-articular gelsolin level increased after treatment with reduction of effusion. No statistically significant evidence of an association between patient demographics and outcome were identified. Nine patients failed treatment, with 32 months mean time to failure and underwent total knee arthroplasty. CONCLUSION: PoC study of GOLDIC® as a novel device for conservative management of moderate to severe KOA was confirmed. GOLDIC® produces rapid and sustained improvements in all indices after treatment, with no SAEs. TRIAL REGISTRATION: § 13 Abs.2b AMG Bavaria (Protokol Reg OBB 5-16) (Ref 53.2-2677.Ph_3-67-2)-Date 3/20/2010 retrospectively registered.

Two-year clinical outcomes of autologous microfragmented adipose tissue in elderly patients with knee osteoarthritis: a multi-centric, international study.

PURPOSE: The aim of this study is to evaluate the outcomes of autologous microfragmented adipose tissue (MFAT) injection in elderly patients with knee osteoarthritis (OA). We hypothesized that MFAT knee infiltration for the treatment of knee OA would yield good clinical results out to two years follow-up. METHODS: Multi-centric, international, open-label study conducted by orthopedic surgery, and/or regenerative medicine facilities utilizing patient registries. Subjects recruited for eligibility. The primary outcome measure was Knee Injury and Osteoarthritis Outcome Score (KOOS). Outcomes and patient factors were compared to baseline, at six, 12, and 24 months. Statistical models were used to assess KOOS subscores and probability of exceeding the Minimally Clinically Important Difference (MCID) or Patient Acceptable Symptom State (PASS), and to assess the effect of the treatment variables on KOOS - Pain. RESULTS: Seventy-five patients, 120 primary treatments, mean age 69.6 years, (95%CI 68.3-70.9), BMI 28.4 (95%CI 27.3-29.6), with KL grade 2 to 4 knee OA treated with a single MFAT injection. KL grades 2 (15.1%), 3 (56.3%), and 4 (28.6%), with 20.8% of knees having previously undergone surgery. Patients with KL grade 2 disease had the best results in KOOS - Pain (P = 0.001), at six, 12, and 24 months. Including advanced KL grade 3 and 4 osteoarthritis patients, significant functional and quality of life success was seen in 106/120 treatments (88.3%, 66 patients) at all follow-up time points. Fourteen treatments (11.7%, 9 patients) failed prior to the study endpoint. CONCLUSION: This study shows that a single-dose MFAT injection leads to clinical, functional, and quality of life improvement at two years in elderly patients, in KL grades 2 to 4 of knee osteoarthritis. These findings provide evidence that this treatment modality could be a safe and effective option to other commonly available treatments in carefully selected patients.

The effectiveness of prolotherapy in treating knee osteoarthritis in adults: a systematic review.

Introduction: Osteoarthritis (OA) often leads to symptoms such as pain, stiffness and decreased function. OA is treated with a wide range of modalities, both conservatively and surgically. Prolotherapy has been used to treat various musculoskeletal problems and has shown some promise. Sources of data: Searches of the electronic databases, PubMed, ISI web of science, PEDro and SPORTDiscus, were conducted for all Level 1-4 studies published from inception through to December 2016. Areas of agreement: Ten studies were evaluated and results show significant improvement in scores for pain, function and range of motion, both in the short term and long term. Patient satisfaction was also high in these patients (82%). Areas of controversy: Meta-analysis was not possible due to heterogeneity of outcome measures and populations. Growing points: Moderate evidence suggests that prolotherapy is safe and can help achieve significant symptomatic control in individuals with OA. Areas for developing research: Future research should focus on larger sample size, standardization of treatment protocol and basic science evidence.