Purpose / Study Question: Do patients serendipitously taking ARB/ACE medication for control of their high blood pression at the time of arthroscopic rotator cuff repair have significantly different shoulder functional shoulder outcomes at 3, 6, and 12 months compared to patients on those medications.?

Background:

Post-operative stiffness after an arthroscopic rotator cuff repair is a well-documented complication/effect in the Orthopedic literature.1,2 Total return of range of motion and timing of this return has real world implications with regards to returning to normal activities of daily living (ADLs) as well as work or sport. While postoperative loss of range of motion is a multifactorial process, including pain, hemarthrosis, and patient hesitancy to reinjure themselves; there is a formation of scar tissue and adhesions that is expected from any violation of the surrounding soft tissue.

Deposition of extracellular matrix and collagen around the area of surgery, for both healing of repaired structures as well as surrounding tissue damaged in the act of surgery, is a normal process. It can be assumed that the more vigorous the response the higher the likelihood of fibrosis, stiffness and the diagnosis of adhesive capsulitis and stiffness in the postoperative period.

Fibrosis, stiffness, and capsular contracture can occur both intra and extr-articular in the shoulder, both spaces which are violated during an arthroscopic rotator cuff repair.3 Multiple different strategies have been investigated to help reduce or minimize this process in the postoperative period.

Recently the profibrotic pathway in healing involving transforming growth factor-beta 1 (TGF-B1) has become an area of interest. TGF-B1 is a key cytokine in formation of fibrosis in numerous areas, including muscle and tendon.4 In theory, blocking the activation of TGF-B1 could reduce fibrotic tissue formation.

Angiotensin II receptor blockers (ARBs) and angiotensin-converting enzyme inhibitors (ACEi), commonly prescribed as antihypertensive agents, have demonstrated activity in blocking TGF-B1 and presumably have antifibrotic effects. Recent publications across many surgical and medical specialties have demonstrated that these presumed antifibrotic effects are real.5-9

Building on this literature recent Orthopedic surgery in both the knee and shoulder literature researching the ACEi and ARBs and their anti TGF-B1 effects with regards to fibrosis, healing and need for further procedures such as manipulation under anesthesia or lysis of adhesions. Premkumar et. al. demonstrated a decreased rate of MUA following TKA in a large study.10

In the shoulder, Bi et al recently published a retrospective cohort study investigating perioperative ARB or ACEi had on arthrofibrosis.11 In their analysis did not significantly

Affect the rate of postoperative arthrofibrosis following shoulder arthroscopy. The authors themselves do admit it is possible their study is underpowered for detecting a significant effect in what is a relatively rare occurrence. Our yet to be published analysis of a openly accessible national database, looking at the occurrence of MUA and Adhesive capsulitis in patients undergoing arthroscopic rotator cuff repair suggests that ACEi and ARBs can be protective of arthrofibrosis.

Currently there is a paucity of literature regarding how ARBs and ACEi effect postoperative range of motion and stiffness. Our proposal is to perform a retrospective review of the patients at the University of Chicago that have undergone arthroscopic rotator cuff repair in the last 15 years and analyze documented range of motion, diagnosis of stiffness/adhesive capsulitis, return to OR for MUA as well as need for revision rotator cuff repair.

Specific Aims:

Aim 1: Compare functional outcomes in the first year in patients who had arthroscopic rotator cuff repair in patients who were on an ACEi or ARB in the perioperative time period compared to those patients who were not on those medications during the perioperative time period.

Hypothesis: Functional outcomes (ROM) strength, complication and revision rates will not differ between the two groups.

Aim 2: Compare reported rate of diagnosis of stiffness/adhesive capsulitis, the incidence of return to or for MUA or lysis of adhesions in patients who had arthroscopic rotator cuff repair in patients who were on an ACEi or ARB in the perioperative time period compared to those patients who were not on those medications during the perioperative time period.

Hypothesis: There would be no difference between the two groups.

Aim 3: Compare the incidence of return to the OR for revision rotator cuff repair in patients who had arthroscopic rotator cuff repair in patients who were on an ACEi or ARB in the perioperative time period compared to those patients who were not on those medications during the perioperative time period.

Hypothesis: there would be no difference between the two groups.

A retrospective chart review will take place to assess upper extremity function after arthroscopic rotator cuff repair on collected data elements and enter into a redcap database with patient identifiers removed and replaced with study numbers. This data will be stored for analysis. Primary data elements includes: Age, gender, weight, height, past medical history, technical details of surgical procedure, postoperative complications, Reported ROM at 3, 6, and 12 months, return to the OR for MUA or lysis of adhesions, return to the OR for revision rotator cuff repair, and any self-reported upper extremity dysfunction.

--Epic Access

-- Excel or Redcap for database management

--SPSS or similar program for statistical analysis

Bi-monthly shoulder research conference. 2nd and 4th Tuesday at 5pm with Shoulder research team.