Tennis elbow, study protocol for a randomized clinical trial: needling with and without platelet-rich plasma after failure of up-to-date rehabilitation.

BACKGROUND: The conservative management of lateral epicondylitis is known to be a difficult-to-treat annoying condition. A treatment with platelet-rich plasma (PRP) is often performed, but its efficacy remains controversial. METHODS: This study is a single-center, randomized double-blind controlled trial, preceded by a case series. All the 232 planned patients of the case series will undergo an up-to-date comprehensive rehabilitation program, including focused extracorporeal shock waves therapy. This rehabilitation program is expected to have a maximum success rate 75%. It is therefore aimed to allocate a minimum of 58 patients with rehabilitation failure into the 1:1 randomized trial. Stratification is planned on age and lesion pattern. The masking will be quadruple (Participant, Care Provider, Investigator & Outcome Assessor). The patients will undergo an ultrasound (US)-guided needling combined with either PRP (intervention group) or saline (control group). The primary endpoint will be the pain improvement from baseline (month 0) at 3 months on a 0-10 visual analog scale (VAS) during a maximal strength isometric contraction of the extensor carpialis brevis muscle. The main secondary endpoints will include the rehabilitation success rate and improvements from baseline at 3, 6, and 12 months of the following outcomes: (i) Single Assessment Numeric Evaluation (SANE) score, (ii) Patient-Rated Tennis Elbow Evaluation (PRTEE) score, (iii) maximal grip strength on Jamar test, and (iv) the ultrasonographic evaluation of the US of the epicondylar tendons. DISCUSSION: The study results will provide insight into the effect of PRP as adjuvant therapy to tendon fenestration, and may contribute to identify the best preceding and concomitant rehabilitation protocol. TRIAL REGISTRATION: ClinicalTrials.gov NCT03987256. Registered on 20 August 2019.

Glenoid loosening and migration in reverse shoulder arthroplasty.

AIMS: The aim of this study was to report the outcomes of different treatment options for glenoid loosening following reverse shoulder arthroplasty (RSA) at a minimum follow-up of two years. PATIENTS AND METHODS: We retrospectively studied the records of 79 patients (19 men, 60 women; 84 shoulders) aged 70.4 years (21 to 87) treated for aseptic loosening of the glenosphere following RSA. Clinical evaluation included pre- and post-treatment active anterior elevation (AAE), external rotation, and Constant score. RESULTS: From the original cohort, 29 shoulders (35%) were treated conservatively, 27 shoulders (32%) were revised by revision of the glenosphere, and 28 shoulders (33%) were converted to hemiarthroplasty. At last follow-up, conservative treatment and glenoid revision significantly improved AAE, total Constant score, and pain, while hemiarthroplasty did not improve range of movement or clinical scores. Multivariable analysis confirmed that conservative treatment and glenoid revision achieved similar improvements in pain (glenoid revision vs conservative, beta 0.44; p = 0.834) but that outcomes were significantly worse following hemiarthroplasty (beta -5.00; p = 0.029). CONCLUSION: When possible, glenoid loosening after RSA should first be treated conservatively, then by glenosphere revision if necessary, and last by salvage hemiarthroplasty Cite this article: Bone Joint J 2019;101-B:461-469.

Functional recovery following early mobilization after middle third clavicle osteosynthesis for acute fractures or nonunion: A case-control study.

BACKGROUND: Good outcomes have been reported after surgical treatment for acute or nonunion of displaced midshaft clavicle fractures. However, the postoperative rehabilitation and timeline for a complete functional recovery are poorly documented. The purpose of the current study was to evaluate the efficacy of an immediate motion protocol following plate fixation of a midshaft clavicle fracture and to compare functional recovery between acute and nonunion cases. METHODS: Between October 2011 and July 2015, all patients above the age of 18, having either an acute or a nonunion of the midshaft clavicle fracture, were considered as potentially eligible for inclusion in this prospective case-control study. Postoperatively, no immobilization was recommended and patients were to undergo rehabilitation protocol consisting of hourly stretching. RESULTS: Forty-two patients were included (31 with acute and 11 with delayed fixation) at a mean follow-up of 33months (range, 12 to 78months). Surgical complications consisted of one transient frozen shoulder, one delayed union, and two superficial infections. All patients returned to work, retrieved full shoulder range of motion (ROM), and returned to heavy sports and activities. Function returned faster in the acute group compared to the nonunion group based on the SANE score at 2weeks (73±21 vs. 45±26 respectively, P=0.01), SANE score at 6weeks (89±15 vs. 66±23 respectively, P=0.01), SANE score at 3months (96±10 vs. 85±14 respectively, P=0.03), and based on return of full ROM (17±25 vs. 44±31 days respectively, P=0.01). A trend was observed for nonunion cases needing more time to return to work and sports activities. CONCLUSION: Functional outcome is excellent following the treatment of both acute and non-united clavicle fractures, but recovery occurs earlier following acute treatment. An early mobilization rehab protocol can be safely recommended for both types of conditions and may result in substantial healthcare cost-savings, without increasing complication rate and decreasing patient satisfaction. LEVEL OF EVIDENCE: Level III; case-control study; treatment study.

Subscapularis and deltoid preserving anterior approach for reverse shoulder arthroplasty.

HYPOTHESIS: We hypothesize that performing a RSA using an anterior approach without cutting the subscapularis tendon and the deltoid muscle could provide patients with superior short-term clinical outcomes and immediate active range of motion (ROM) without immobilization. METHODS: Between August 2013 and June 2015, all patients who had a primary RSA were considered potentially eligible for inclusion in this prospective study. RESULTS: No immediate intra- or postoperative complications were noted. A statistically significant improvement of VAS (from 6.7 to 1; P<.001), SANE (from 34 to 80; P<.001), and elevation (from 103° to 128°; P=.02) was observed. In some cases, patients who had pseudoparalysis preoperative were able to achieve full anterior elevation few days after the operation. DISCUSSION: Using a subscapularis and deltoid preserving anterior approach is an option for patients requiring RSA. Leaving this tendon intact and preserving the deltoid minimize the need for immediate postoperative immobilization and allow for faster recovery of shoulder ROM, without risking the concern of humeral anterior dislocation. Overall duration of hospital stay as well as length of postoperative physical therapy may be minimized, with substantial long-term economic gain. Longer follow-up and comparison with standard approaches is necessary in the future. LEVEL OF EVIDENCE OF THE STUDY: Level IV, case series with no comparative group.

GABAergic drug use and global, cognitive, and motor functional outcomes after stroke.

BACKGROUND: In animal models and healthy volunteers, the use of GABA A receptor agonists (GABA-AGs) seem deleterious for functional recovery. The agents are widely used for subacute stroke, but their effect on functional recovery remains unclear. OBJECTIVES: We aimed to evaluate the association between GABA-AG use and functional recovery after stroke. METHODS: We retrospectively recruited 434 survivors of subacute stroke admitted for inpatient rehabilitation between 2000 and 2013 in our institution (107 with and 327 without GABA-AG use). We used multivariate regression to assess the association of GABA-AG use and successful functional recovery, defined as reaching, between admission and discharge, the minimal clinically important difference (MCID) of 22 points on the global Functional Independence Measure (FIM). Secondary analyses were the associations of GABA-AG with cognitive and motor FIM MCID and constant GABA-AG exposure (24h/24 GABA-AG) with global, cognitive and motor FIM MCID. A new estimation of the MCID was performed with the standard error of measurement. RESULTS: Reaching the global FIM MCID was associated with GABA-AG use (adjusted odds ratio [aOR] 0.54 [95% CI 0.31-0.91], P=0.02) as well as 24h/24 GABA-AG use (aOR 0.25 [0.08-0.83]; P=0.02). Furthermore, GABA-AG and 24h/24 GABA-AG use was inversely but not always significantly associated with reaching the cognitive FIM MCID (aOR 0.56, P=0.07; aOR 0.26, P=0.06, respectively) and motor FIM MCID (aOR 0.51, P=0.07; aOR 0.13, P=0.01, respectively). The estimated MCID was 19 for global FIM, 4 for cognitive FIM, and 16 for motor FIM. CONCLUSIONS: GABA-AG use is associated with not reaching successful functional recovery during stroke rehabilitation. Randomised trials are needed to formally establish the potential deleterious effect of GABA-AG use on functional recovery.

In vivo clinical and radiological effects of platelet-rich plasma on interstitial supraspinatus lesion: Case series.

BACKGROUND: Rotator cuff tear (RCT) is a frequent condition of clinical relevance that can be managed with a symptomatic conservative treatment, but surgery is often needed. Biological components like leukocytes and platelet rich plasma (L-PRP) could represent an alternative curative method for interstitial RCT. HYPOTHESES: It has been hypothesized that an ultrasound guided L-PRP injection in supraspinatus interstitial RCT could induce radiological healing. MATERIAL AND METHODS: A prospective case series including 25 patients was performed in order to assess the effect of L-PRP infiltration into supraspinatus interstitial RCTs. Primary outcome was tear size change determined by magnetic resonance imaging arthrogram (MRA) before and 6 months after L-PRP infiltration. Secondary outcomes were Constant score, SANE score, and pain visual analog scale (VAS) after L-PRP infiltration. RESULTS: Tear volume diminution was statistically significant (P=.007), and a >50% tear volume diminution was observed in 15 patients. A statistically significant improvement of Constant score (P<.001), SANE score (P=.001), and VAS (P<.001) was observed. In 21 patients, Constant score improvement reached the minimal clinical important difference of 10.4 points. DISCUSSION: We observed a statistically significant and clinically relevant effect on RCT size and clinical parameters after L-PRP infiltration. Such an important improvement of supraspinatus interstitial RCT with conservative management is uncommon, therefore intratendinous L-PRP infiltrations could have been beneficial. This encouraging result could pave the way for future randomized studies in order to formally determinate whether L-PRP infiltrations are a possible alternative to surgical treatment of interstitial RCT. LEVEL OF EVIDENCE: Prospective observational study; Level of evidence II.