Evidence map›Paper›PMID 38762734›Full record

Trial reportBMC musculoskeletal disorders2024

Percutaneous bone marrow concentrate and platelet products versus exercise therapy for the treatment of rotator cuff tears: a randomized controlled, crossover trial with 2-year follow-up.

Christopher J Centeno, Zachary Fausel, Ehren Dodson, Dustin R Berger, Neven J Steinmetz

Registry-linked trialAbstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in BMC musculoskeletal disorders, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01788683 (A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Non-retracted Supraspinatus Tendon Tears), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01788683 nacompletednot on this map

A Randomized Controlled Trial of Regenexx™ SD Versus Exercise Therapy for Treatment of Non-retracted Supraspinatus Tendon Tears

TypeinterventionalSponsorRegenexx, LLCRan2013 to 2022Enrolled51ConditionsRotator Cuff TearArmsRegenexx SD, Exercise Therapy
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Christopher J CentenoCenteno-Schultz Clinic, Broomfield, CO, 80021, USA.
Zachary FauselRegenexx, LLC, Research and Development, Broomfield, CO, 80021, USA.
Ehren DodsonRegenexx, LLC, Research and Development, Broomfield, CO, 80021, USA. edodson@regenexx.com.
Dustin R BergerRegenexx, LLC, Research and Development, Broomfield, CO, 80021, USA.
Neven J SteinmetzRegenexx, LLC, Research and Development, Broomfield, CO, 80021, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSurgical repair is recommended for the treatment of high-grade partial and full thickness rotator cuff tears, although evidence shows surgery is not necessarily superior to non-surgical therapy. The purpose of this study was to compare percutaneous orthobiologic treatment to a home exercise therapy program for supraspinatus tears.

methodsIn this randomized-controlled, crossover design, participants with a torn supraspinatus tendon received either 'BMC treatment', consisting of a combination of autologous bone marrow concentrate (BMC) and platelet products, or underwent a home exercise therapy program. After three months, patients randomized to exercise therapy could crossover to receive BMC treatment if not satisfied with shoulder progression. Patient-reported outcomes of Numeric Pain Scale (NPS), Disabilities of the Arm, Shoulder, and Hand, (DASH), and a modified Single Assessment Numeric Evaluation (SANE) were collected at 1, 3, 6, 12, and 24 months. Pre- and post-treatment MRI were assessed using the Snyder Classification system.

resultsFifty-one patients were enrolled and randomized to the BMC treatment group (n = 34) or the exercise therapy group (n = 17). Significantly greater improvement in median ΔDASH, ΔNPS, and SANE scores were reported by the BMC treatment group compared to the exercise therapy group (-11.7 vs -3.8, P = 0.01; -2.0 vs 0.5, P = 0.004; and 50.0 vs 0.0, P < 0.001; respectively) after three months. Patient-reported outcomes continued to progress through the study's two-year follow-up period without a serious adverse event. Of patients with both pre- and post-treatment MRIs, a majority (73%) showed evidence of healing post-BMC treatment.

conclusionsPatients reported significantly greater changes in function, pain, and overall improvement following BMC treatment compared to exercise therapy for high grade partial and full thickness supraspinatus tears.

trial registrationThis protocol was registered with www. CLINICALTRIALS: gov (NCT01788683; 11/02/2013).

Indexed as

Bone Marrow TransplantationCross-Over StudiesExercise TherapyRotator Cuff InjuriesAdultAgedFemaleFollow-Up StudiesHumansMagnetic Resonance ImagingMaleMiddle AgedPain MeasurementPatient Reported Outcome MeasuresRotator CuffTreatment OutcomeAutologous orthobiologicsBone marrow concentrate (BMC)Cell therapyExercise therapyMusculoskeletal painPlatelet-rich plasma (PRP)Rotator cuff tearsShoulder

Identifiers

PMID38762734
PMCPMC11102209

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.