"We need a randomized controlled trial to determine whether patients with shoulder arthritis having a pyrocarbon humeral head have better outcomes than those having a ream and run".
In discussing this topic it may be worthwhile starting with a classic example of an orthopaedic RCT
A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee The reader will easily see the care exerted by the investigators to define the two groups to be compared (debridement vs sham surgery, the randomization, the blinding of the evaluators, the primary outcome measure (the Knee-Specific Pain Scale), and the outcomes ("At no point did either of the intervention groups report less pain or better function than the placebo group. Furthermore, the 95 percent confidence intervals for the differences between the placebo group and the intervention groups exclude any clinically meaningful difference.") Interestingly, in spite of this result, arthroscopic debridement for knee osteoarthritis is still being performed.
Before considering a randomized controlled trial, investigators must listen to this recent presentation: American Shoulder and Elbow Surgeons webinar on randomized controlled trials. This very well done webinar was both impressive and daunting. It pointed out the organization, cost and the challenges of RCTs.
Stimulated by the above, I started making a check list of questions to be answered before considering an RCT comparing pyrocarbon humeral hemiarthroplasty to the ream and run procedure. I suspect that there are others that should be included.
I. What should be the primary outcome variable (POV)?
A. Wear rate
B. Patient reported outcome measure (PROM)
1. Final PROM
2. Change in PROM
B. Satisfaction
C. Complication rate (e.g. infections)
D. Revision rate
II. How long after surgery should the POV be assessed
III. For the selected POV, what are the published mean, median, standard deviation, and 90% confidence levels for
A. Pyrocarbon humeral hemiarthroplasty
B. Ream and run procedure
IV. How much change in the selected POV would be clinically significant (effect size)
V. What sample size would be necessary to detect a clinically significant change in the POV with reasonable statistical power (e.g. 80%) (see Sample size, power and effect size revisited: simplified and practical approaches in pre-clinical, clinical and laboratory studies)
VI. What percent of the potential candidates for the study would agree to be enrolled in a study that had their surgical procedure selected at random; in what ways do consenting and non-consenting patients differ?
VII. What percent of those enrolled are likely to drop out before the desired followup time interval; in what ways do patients not completing the study differ from those that complete it?
VIII. What are the confounding variables and how will they be documented and included in the analysis
A. The surgeon (experience, published outcomes)
B. The component (make, size, stem, position)
C. Patient demographics (age, sex, comorbidities)
D. Preoperative pathology (type of arthritis, glenoid type, version, cuff status, centering, shoulder size, prior surgery)
E. Simultaneous procedures (glenoid reaming (accepting or correcting glenoid version), biceps management (preservation, tenotomy, tenodesis), posterior capsular plication, rotator interval plication, cuff surgery, AC joint surgery)
IX. Study details
A. How will decisions be made
B. Prospective involvement of statistician
C. Initial and followup meeting of investigators
D. Where will data be housed
E. Human subjects clearances
1. Locally at each study site
2. Centrally
F. Staffing
G. Funding
H. How will blinding be managed (patient, followup, etc)
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Here are some videos that are of shoulder interest
Shoulder arthritis - what you need to know (see this link).
How to x-ray the shoulder (see this link).
The ream and run procedure (see this link).
The total shoulder arthroplasty (see this link).
The cuff tear arthropathy arthroplasty (see this link).
The reverse total shoulder arthroplasty (see this link).
The smooth and move procedure for irreparable rotator cuff tears (see this link)
Shoulder rehabilitation exercises (see this link).
