Dataset Information

A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis.

ABSTRACT: Injectable regenerative therapies such as bone marrow concentrate (BMC) and platelet-rich plasma (PRP) may represent a safe alternative in the treatment of rotator cuff tears. This is a midterm review of a randomized, crossover trial comparing autologous BMC and platelet product injections versus exercise therapy in the treatment of partial and full-thickness supraspinatus tears. Patients enrolled into the study were between 18 and 65 years of age presenting to an outpatient orthopedic clinic with partial to full thickness, nonretracted supraspinatus tendon tears. Enrolled patients were randomized to either ultrasound-guided autologous BMC with PRP and platelet lysate (PL) percutaneous injection treatment or exercise therapy. Patients could cross over to BMC treatment after at least 3 months of exercise therapy. Patients completed the Disability of the Arm, Shoulder and Hand (DASH) scores as the primary outcome measure. Secondary outcomes included the numeric pain scale (NPS), a modified Single Assessment Numeric Evaluation (SANE), and a blinded MRI review. At this midterm review, results from 25 enrolled patients who have reached at least 12-month follow-up are presented. No serious adverse events were reported. Significant differences were seen in patient reported outcomes for the BMC treatment compared to exercise therapy at 3 and 6 months for pain, and for function and reported improvement (SANE) at 3 months (p < .05). Patients reported a mean 89% improvement at 24 months, with sustained functional gains and pain reduction. MRI review showed a size decrease of most tears post-BMC treatment. These findings suggest that ultrasound-guided BMC and platelet product injections are a safe and useful alternative to conservative exercise therapy of torn, nonretracted supraspinatus tendons. This trial is registered with NCT01788683.

SUBMITTER: Centeno C

PROVIDER: S-EPMC7204132 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis.

Centeno Christopher C Fausel Zachary Z Stemper Ian I Azuike Ugochi U Dodson Ehren E

Stem cells international 20200130

Injectable regenerative therapies such as bone marrow concentrate (BMC) and platelet-rich plasma (PRP) may represent a safe alternative in the treatment of rotator cuff tears. This is a midterm review of a randomized, crossover trial comparing autologous BMC and platelet product injections versus exercise therapy in the treatment of partial and full-thickness supraspinatus tears. Patients enrolled into the study were between 18 and 65 years of age presenting to an outpatient orthopedic clinic wi ...[more]

PMID: 32399045

Similar Datasets

Project description:PurposeAcute trauma-related rotator cuff tears are believed to have better healing potential than chronic tears due to less degenerative changes of the tendons. However, the histopathological condition of tendons from trauma-related tears is not well investigated. The purpose of this study was to explore specific histopathological features in tendons from acute trauma-related full-thickness rotator cuff tears and to compare them to findings in tendons from nontraumatic, chronic tears.MethodsIn a prospective cohort study, 62 previously asymptomatic patients [14 women, median age 61 years (range 42-75)] with trauma-related full-thickness rotator cuff tears were consecutively included. Arthroscopic repair was performed within 30 (median, IQR 25-37) days after the injury. During surgery, tissue biopsies were harvested from the supraspinatus tendons in 53 (86%) of the patients. In addition, similar biopsies were harvested from 10 patients undergoing surgery for chronic tears without history of trauma. All tissue samples were examined by a well-experienced pathologist under light microscope. Tendon degeneration was determined using the Bonar score whereas immunostaining was used for proliferation (Ki67), inflammation (CD45), apoptosis (p53) and haemosiderin staining to study traces of bleeding.ResultsThe median (IQR) Bonar score for the acute trauma-related biopsies was 10.5 (7.5-14.5) compared to 11 (5-12.8) for the control group with no statistically significant difference between the groups. No statistically significant between-group difference was found for the inflammatory index whereas tendons from patients with trauma-related full-thickness rotator cuff tears had statistically significantly higher apoptosis [3.1 (0.5-8.9) vs. 0.1 (0-1.5), p = 0.003] and proliferation [4.0 (1.8-6.9) vs. 0.4 (0-2.0), p = 0.001) indices than those undergoing surgery for chronic tears. Positive haemosiderin staining was found in 34% of tissue samples from patients with trauma-related tears compared to 10% in the control group (n.s).ConclusionThis study suggests that there is no difference with regard to degenerative changes between supraspinatus tendons harvested from patients with acute, trauma-related rotator cuff tears and patients with nontraumatic, chronic tears.Level of evidenceII.

Project description:PurposeTo determine whether anterior cable tears could be identified at the time of arthroscopic rotator cuff repair and determine the characteristics of the anterior cable tears identified.MethodsFrom 2016 to 2017 all shoulder arthroscopies had data collected prospectively at the time of surgery, specifically including injury to the capsular and tendon zones of insertion on the greater tuberosity. Anterior cable position and degree of injury and medialization were recorded, as well as complete findings of the diagnostic arthroscopy. The inclusion criterion was primary shoulder arthroscopy. The exclusion criterion was any revision shoulder arthroscopy. All arthroscopic rotator cuff repairs (ARCR) were grouped together and all other nonarthroscopic rotator cuff repair surgeries (non-ARCR) were grouped together.ResultsIn total, 118 shoulder arthroscopies had data collected prospectively at the time of surgery: 90 primary shoulder arthroscopies met the inclusion criteria; 28 were excluded because they were revision surgeries. There were 42 patients in the ARCR group (Group 1). Six of these were partial tears, and 36 were full-thickness tears. There were 48 patients in the non-ARCR group (Group 2). The non-ARCR Group 2 served as an anatomic baseline for ARCR Group 1. In all 90 shoulders, the rotator cable and anterior cable were identified. Group 1 (ARCR) incidence of anterior cable tears with abnormal position was 71.4% compared to 2.1% in group 2 (non-ARCR) (P < .001) Group 1 (ARCR) incidence of anterior cable tears with normal anterior cable position (n = 12) was compared to abnormal anterior cable position (n = 30). Injury to the anterior footprint capsular and tendon zones were compared. Normal anterior cable position correlated with no or low-grade injury to anterior footprint capsular zone. (Nimura zone C1). Abnormal anterior cable displacement graded as moderate (n = 20) and severe (n = 10) were compared for injury to the anterior footprint. Moderate displacement correlated with complete or high grade injury to C1 in 85% and complete injury to R1 in 45% (P < .001 and .049). In severe displacement complete C1 injury was 100%, and complete R1 injury was 100% (P < .001 and .001).ConclusionsAnterior cable tears are universally identified in ARCR. Three patterns of medial displacement severity correlated with injury to a crucial insertion zone (C1) at the anterior footprint. The degree of anterior cable disruption at the anterior footprint and displacement was commonly disproportionately greater than the injury to the supraspinatus.Level of evidenceLevel III, diagnostic study.

Project description:BACKGROUND:Bone marrow concentrate (BMC) has shown promise in the treatment of several orthopedic conditions. This registry study investigated the use of autologous BMC and platelet products for percutaneous anterior cruciate ligament (ACL) treatment. METHODS:Twenty-nine patients presenting to a single outpatient interventional musculoskeletal and pain practice with symptomatic grade 1, 2, or 3 ACL tears with less than 1 cm retraction were enrolled. Patients were treated with a percutaneous ACL injection of autologous BMC and platelet products using fluoroscopic guidance. Pre- and post-treatment magnetic resonance imaging analysis was completed for 23 patients using ImageJ software for an objective quantitative analysis of pixel density as a proxy for ACL integrity. Subjective clinical outcome measures collected pre-treatment and at 1, 3, 6, 12, 18, 24, and 36 months post-treatment include the Numerical Pain Scale (NPS), the Lower Extremity Functional Scale (LEFS), the International Knee Documentation Committee (IKDC) form, and a modified version of the Single Assessment Numeric Evaluation. RESULTS:Seventy-seven percent of patients treated with BMC injections into the ACL showed significant improvement (p?<?0.01) in objective measures of ACL integrity at an average of 8.8 months (median 4.7 months). The mean of last patient-reported improvement was 72% (SD?=?35) at an average of 23 (SD?=?10) months post-treatment. Mean scores were found to be significantly different (p?<?0.05) for the NPS at 6, 18, and 24 months, and LEFS and IKDC at all time points (i.e. 1, 3, 6, 12, 18, 24, and 36 months) relative to baseline. CONCLUSION:In symptomatic patients with grade 1, 2, or even grade 3 tears with minimal retraction, ACL treatment with percutaneous injection of BMC and platelet products shows promise as a non-surgical alternative. However, a larger randomized controlled trial is warranted to confirm these findings. Trial registration NCT03011398. A Clinical Registry of Orthobiologics Procedures. https://clinicaltrials.gov/ct2/show/NCT03011398?term=orthobiologics&rank=1 . Registered 29 December 2016. Enrollment 1 December 2011-retrospectively registered.

Project description:OBJECTIVE:Patients who underwent arthroscopic repair for partial rotator cuff tears were evaluated retrospectively. This study purposed to assess the postoperative clinical results of arthroscopic treatment of intratendinous rotator cuff tears and to investigate the effect of the tear type on the postoperative clinical outcomes. METHODS:Overall, 60 patients [36 women and 24 men; mean age: 48.6±12.2 years (range 33-67 years)] who underwent arthroscopic repair of Ellman stage 3 partial rotator cuff tear were evaluated retrospectively. These patients were grouped into the following three groups: articular-sided tears, bursal-sided tears, and intratendinous tears, with 20 patients included in each group. Subacromial decompression, acromioplasty, and tear repair without transforming to full-thickness tear were applied to the bursal-sided tears. The same technique was performed for intratendinous ruptures, with the only technical difference was that the capsular tissue was preserved during debridement of intratendinous tears. The articular-sided tears were transformed to complete tears and repaired arthroscopically. The preoperative and postoperative ASES scores and range of motion improvements were evaluated in all patients. The mean follow-up time was 44±6.5 months (range: 36-62 months). RESULTS:No significant intergroup differences were observed concerning the age and the mean follow-up duration (p=0.524, p=0.665). A similar increase in ASES scores was observed for all three types of tears (bursal-sided tears: 31.09-82.65; articular-sided tears: 35.50--84.00; intratendinous tears: 34.01-83.49). Statistically, no significant intergroup difference was observed concerning ASES score improvement (p=0.585). An increase in mean forward flexion, abduction, and external rotation were observed, especially, a statistically significant increase in flexion (p=0.001) and abduction (p=0.001) in all three types of tears. No patient experienced any intraoperative or postoperative complications. CONCLUSION:The results of arthroscopic treatment of intratendinous tears were similar to the other types of partial tears, and the results of arthroscopic treatment of grade 3 partial rotator cuff tears revealed satisfactory outcomes, regardless of the type of the tear. LEVEL OF EVIDENCE:Level III, Therapeutic study.

Dataset Information

A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis.

Publications

A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets