Flexion Therapeutics (United States)

As anatomic shoulder arthroplasty continues to increase in popularity, there will be a similar need for revising these implants to reverse total shoulder arthroplasty. To address this problem, convertible glenoid and humeral components have been developed to facilitate a less complicated, less traumatic, and bone-preserving procedure. However, convertible glenoids have a historically higher failure rate due to loosening and joint overstuffing when used for anatomic shoulder arthroplasty, and convertible humeral stems can be problematic at the time of revision and often need to be removed because of stem malposition. Despite these issues, there have been recent advances with the humeral and glenoid components which continue to make these implant options appealing and relevant. At the same time, there is a trend toward stemless arthroplasty which makes a convertible humeral stem less important due to the ease of revision from a stemless component to a stemmed reverse shoulder arthroplasty.

In an effort to preserve bone, humeral stems in reverse total shoulder arthroplasty (RTSA) have gradually decreased in length. The purpose of this study was to compare the immediate postoperative radiographic appearance of short-length with standard-length RTSA stems. Patients who underwent RTSA using a press-fit standard-length or short-length humeral implant with a consistent geometry (Univers Revers or Revers Apex) were evaluated in a multicenter retrospective review. Initial postoperative radiographs were used to assess initial alignment and filling ratios. In addition, radiographs were evaluated for early signs of stress shielding and/or loosening. Clinical outcome scores and range of motion were also evaluated. Overall, 137 short-length stems and 139 standard-length stems were analyzed. Initial radiographs demonstrated a significantly higher percentage of stems placed in neutral alignment in the short-stem group (95.6% vs 89.2%, P = 0.045). Similar metaphyseal filling ratios were seen between groups, but a significantly higher diaphyseal filling ratio was observed in the short-stem group (57% vs 34%, P < 0.001). Less calcar osteolysis (2.2% vs 12.9%; P = 0.001) and fewer overall number of radiographic changes (tuberosity resorption, lucencies, and subsidence) (0.7% vs 5.0%; P = 0.033) were seen with short stems compared with the standard-length stems. RTSA with a short-stem humeral implant demonstrates excellent radiographic outcomes, including low rates of loosening and subsidence at 1 year, with less early calcar osteolysis compared with a standard-length stem. III (Case-control).

Rotator cuff repair (RCR) is commonly performed before reverse shoulder arthroplasty (RSA) with conflicting evidence on the effect on arthroplasty outcomes. The purpose of this investigation was to evaluate the effect of a prior RCR on the outcomes and complications of primary RSA. Between 2007 and 2017, 438 RSAs performed in patients with a prior RCR and 876 case-matched controls were identified from a multicenter database. Patients were grouped based on a preoperative diagnosis of glenohumeral osteoarthritis (GHOA) and rotator cuff tear arthropathy (CTA). Data collected included range of motion, strength, complications, and revisions. Additional clinical metrics included American Shoulder and Elbow Society score, Constant score, Shoulder Pain and Disability Index, Simple Shoulder Test, and the University of California Los Angeles shoulder score. Compared with controls, both GHOA and CTA study groups demonstrated lower postoperative forward elevation (FE) (133° versus 147°, P < 0.001; 133° versus 139°, P = 0.048) and FE trength (6.5 versus 8.2, P = 0.004; 6.1 versus 7.3, P = 0.014). In addition, inferior improvements were observed in the GHOA and CTA study groups with respect to abduction (38° versus 52°, P = 0.001; 36° versus 49°, P = 0.001), FE (41° versus 60°, P < 0.001; 38° versus 52°, P = 0.001), ER (16° versus 25°, P < 0.001; 10° versus 17°, P = 0.001), and Constant score (28.4 versus 37.1, P < 0.001; 26.2 versus 30.9, P = 0.016). Compared with controls, no differences were observed in the GHOA and CTA study groups with respect to notching (11.2% versus 5.6%, P = 0.115; 5.8% versus 7.9%, P = 0.967), complications (4.3% versus 1.6%, P = 0.073; 2.5% versus 2.7%, P = 0.878), and revision surgery (3.1% versus 0.9%, P = 0.089; 1.1% versus 1.3%, P = 0.822). RSA after a prior RCR improves both pain and function, without increasing scapular notching, complications, or revision surgery. However, compared with patients without a prior RCR, postoperative shoulder function may be slightly decreased. III; Retrospective Cohort Study.

Partial anterior cruciate ligament (ACL) tears comprise an estimated 10% to 27% of isolated ACL injuries. Partial ACL tears may be challenging to clinically diagnose. We reviewed relevant studies focusing on the anatomy, diagnosis, imaging, and treatment of a partial injury with the goal of providing guidance to clinicians. Although a comprehensive patient history, thorough clinical examination, and imaging studies are helpful in arriving at a diagnosis, the benchmark for diagnosis remains visualization and examination of the ACL at the time of knee arthroscopy. Currently, limited data exist about the long-term outcomes of nonsurgical treatment. Some studies demonstrate that younger, active patients have the risk of progressing to a complete ACL rupture with conservative treatment. The decision to proceed with surgery is based on careful history and physical examination findings that suggest either a "functional" or "nonfunctional" ACL. Surgical treatment consists of augmenting the intact bundle with a selective bundle reconstruction versus a traditional ACL reconstruction. Selective bundle reconstruction has limited data available but is an option. The best evidence supports traditional ACL reconstruction for the surgical management of patients with documented nonfunctional partial tears of the ACL.

Background:Intra-articular corticosteroids relieve osteoarthritis pain, but rapid systemic absorption limits efficacy. FX006, a novel, microsphere-based, extended-release triamcinolone acetonide (TA) formulation, prolongs TA joint residence and reduces systemic exposure compared with standard TA crystalline suspension (TAcs). We assessed symptomatic benefits and safety of FX006 compared with saline-solution placebo and TAcs.Methods:In this Phase-3, multicenter, double-blinded, 24-week study, adults ≥40 years of age with knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) and average-daily-pain (ADP)-intensity scores of ≥5 and ≤9 (0 to 10 numeric rating scale) were centrally randomized (1:1:1) to a single intra-articular injection of FX006 (32 mg), saline-solution placebo, or TAcs (40 mg). The primary end point was change from baseline to week 12 in weekly mean ADP-intensity scores for FX006 compared with saline-solution placebo. Secondary end points were area-under-effect (AUE) curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with saline-solution placebo, AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, change in weekly mean ADP-intensity scores from baseline to week 12 for FX006 compared with TAcs, and AUE curves of the change in weekly mean ADP-intensity scores from baseline to week 24 for FX006 compared with saline-solution placebo. Exploratory end points included week-12 changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QOL) subscale scores for FX006 compared with saline-solution placebo and TAcs. Adverse events were elicited at each inpatient visit.Results:The primary end point was met. Among 484 treated patients (n = 161 for FX006, n = 162 for saline-solution placebo, and n = 161 for TAcs), FX006 provided significant week-12 improvement in ADP intensity compared with that observed for saline-solution placebo (least-squares mean change from baseline: −3.12 versus −2.14; p < 0.0001) indicating ∼50% improvement. FX006 afforded improvements over saline-solution placebo for all secondary and exploratory end points (p < 0.05). Improvements in osteoarthritis pain were not significant for FX006 compared with TAcs using the ADP-based secondary measures. Exploratory analyses of WOMAC-A, B, and C and KOOS-QOL subscales favored FX006 (p ≤ 0.05). Adverse events were generally mild, occurring at similar frequencies across treatments.Conclusions:FX006 provided significant, clinically meaningful pain reduction compared with saline-solution placebo at week 12 (primary end point).Level of Evidence:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.