Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00756015 |
| Other study ID # |
HRPO 07-0915 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 18, 2008 |
| Last updated |
October 11, 2013 |
| Start date |
November 2007 |
| Est. completion date |
August 2012 |
Study information
| Verified date |
October 2013 |
| Source |
Washington University School of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Institutional Review Board |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to better understand the influence of post-operative
rehabilitation on the rate of tendon healing and clinical outcomes following arthroscopic
repair of the rotator cuff. There are two schools of thought on what type of therapy program
is most beneficial following surgical cuff repair. However there has been little data
available to compare them. Therefore, the investigators would like to compare these two
standard plans of care so that the investigators may better define the safety and efficacy
of early mobilization of the shoulder versus keeping the shoulder immobilized following
surgical management.
Description:
Background
Rotator cuff disease is the leading cause of shoulder pain and disability. Previous studies
regarding the epidemiology of rotator cuff disease have demonstrated a high incidence of
age- related cuff tears, approximately 50% of individuals over the age of 55 years 1-3.
Failure of conservative treatment often leads to surgical repair of the torn rotator cuff
tendons. Indeed, rotator cuff repair is one of the most common surgical procedures currently
performed in the shoulder with approximately 200,000 Americans undergoing this surgery
yearly. We estimate that the Shoulder and Elbow Service at Washington University performs
approximately 400 rotator cuff repairs per year.
One of the primary concerns following repair of the rotator cuff is healing of the repaired
tendon. Although pain relief and improved shoulder function are predictable following
rotator cuff repair, the rate of healing of the tendon repair has been much less consistent.
In most instances, the repaired tissue is degenerative, 4, 5 possesses a poor blood supply 6
and, therefore, a limited ability to heal following repair. The rates of healing of the
repaired cuff tendons have ranged from 6% to 80% across multiple studies depending on a
variety of patient, tendon tear and surgery related factors 7-13. The major factors that
have been identified to effect healing after rotator cuff repair include patient age, the
size of the tear and the strength of the repair construct 8, 9, 12. To this point, there has
been little data regarding the potential influence of postoperative rehabilitation of the
shoulder on the structural integrity of rotator cuff repairs.
The Shoulder and Elbow Service at Washington University has had extensive experience in
studying various factors related to not only the progression of rotator cuff disease, but
also tendon healing and outcomes of treatment 8, 14-16. A strength of our research team has
been the collaborative experience developed with musculoskeletal radiologists at the
Mallinkrodt Institute using high-resolution ultrasound to examine the integrity of the
rotator cuff. Extensive data with ultrasound at this institution has validated it as a
highly accurate means of identifying and quantifying rotator cuff tears in both the
preoperative and postoperative settings 17-20. High-resolution ultrasound, in the hands of
experienced musculoskeletal radiologists, has been proven to be more accurate than magnetic
resonance imaging in assessing the integrity of the rotator cuff in the postoperative
setting 19. With this modality, we have been able to study the outcomes and tendon healing
rates following repair of the rotator cuff using conventional arthroscopic repair techniques
8. Recent data, from this institution, has also been completed examining the clinical
outcomes and repair integrity following newer arthroscopic techniques (double-row rotator
cuff repairs) in three separate patient populations: partial thickness cuff tears, full
thickness cuff tears and revision of recurrent rotator cuff tears (manuscripts in progress).
Our service has also been currently involved in a NIH R01 funded study prospectively
examining factors related to the progression of asymptomatic rotator cuff tears over time.
Given our research experience with ultrasound, the Shoulder and Elbow Service at Washington
University has been uniquely positioned to study one of the most important issues in
shoulder surgery - the effect of rehabilitation on healing of the rotator cuff following
surgical repair.
In addition to tendon healing, one of the primary goals following shoulder surgery is the
early restoration of range of motion of the joint. Stiffness is one of the more common
complications following shoulder surgery. Early range of motion helps to prevent the
formation of adhesions within the joint and surrounding capsule and ligaments. Although most
cuff repair constructs provide sufficient stability for early range of motion, the effect of
motion at the repair site and the subsequent effect on healing are unknown in humans.
Concerns regarding a deleterious effect of early motion on tendon healing have led some
investigators to advocate substantially more conservative rehab after surgery. A delay in
motion at the shoulder may theoretically improve the rate of tendon healing as stresses are
minimized across the tendon repair site. This may be particularly important given that
tendon repair constructs gradually becomes weaker before a more mature healing response
occurs. However, a delay in motion will slow the return of mobility to the shoulder and may
increase the risk of prolonged stiffness. Therefore, the clinician must balance the
potential benefit (prevention of stiffness) against the potential harm (compromise of the
surgical repair) of early rehabilitation following rotator cuff repair surgery. Despite the
critical role early motion may have, there have been no published studies examining the
influence of postoperative rehabilitation on the clinical outcomes and repair integrity
following rotator cuff repair.
The primary purpose of this study is to examine the influence of postoperative
rehabilitation on the rate of tendon healing and clinical outcomes following arthroscopic
repair of the rotator cuff. The ideal rehabilitation protocols following rotator cuff repair
have yet to be determined. The clinical impact of this study will be significant in that we
will better define the safety and efficacy of early mobilization of the shoulder following
the surgical management of rotator cuff tears. A better understanding of appropriate
postoperative physical therapy regimens is fundamental to the effective care of patients
following rotator cuff repair. This study will serve as a basis for further research
defining nonsurgical factors that influence tendon healing and outcome after rotator cuff
repair.
Specific Aim 1: To prospectively compare the rate of tendon healing following arthroscopic
repair of small and medium sized tears of the rotator cuff in patients treated with two
distinct postoperative rehabilitation protocols: immobilization versus early range of
motion.
Hypothesis 1: The rate of tendon healing following repair of small to medium sized rotator
cuff tears will be the same for those patients treated with immobilization compared to an
early range of motion protocol.
Specific Aim 2: To prospectively compare the clinical outcomes following arthroscopic repair
of small and medium sized tears of the rotator cuff in patients treated with two distinct
postoperative rehabilitation protocols: immobilization versus early range of motion.
Hypothesis 2: The clinical results following repair of small to medium sized rotator cuff
tears will be substantially better for those patients treated with an early range of motion
protocol as compared to those that were immobilized.
A preliminary power analysis has been performed to determine the necessary number of
patients for each group (alpha level =.05 and beta level = .20). Data from this institution
suggests an 80% healing rate within this age group for small and medium size rotator cuff
tears fixed with double-row cuff repair techniques. Given a presumed healing rate of 80% in
the immobilization group, the numbers necessary to detect a difference in healing of 20%
between the two rehabilitation protocols is 70 subjects in each group. Assuming a
conservative attrition rate of 20%, we will estimate that a total of 170 subjects will need
to be enrolled in this study.
All rotator cuff repairs will be performed with a standard technique utilizing arthroscopic
double-row suture anchor constructs. The surgery will also include subacromial decompression
and acromioplasty as dictated by acromial degenerative changes. Concomitant procedures
related to the biceps tendon will be performed as indicated. At the time of preoperative
surgical evaluation, patients will be randomized by sealed envelope into one of two
postoperative rehabilitation groups:
Immobilization group: 6 weeks of sling shoulder immobilization. Immediate range of motion of
the elbow, forearm, wrist and hand. At 6 weeks, PROM and stretching of the shoulder allowed
under therapist direction. At 12 weeks, AAROM and AROM exercises will be initiated and
capsular stretching advanced until full ROM achieved. Strengthening activities of the
rotator cuff, deltoid and scapular stabilizers will be permitted at 4 months post surgery.
Early range of motion group: Shoulder pendulum exercises will be allowed from the time of
surgery. Immediate range of motion of the elbow, forearm, wrist and hand. At the first
postoperative visit, PROM of the shoulder will be permitted under therapist direction.
Patients will avoid IR and behind the back stretching. At 6 weeks, AAROM and AROM will be
advanced as tolerated. Capsular stretching will be advanced until full range of motion is
achieved. Strengthening activities of the rotator cuff, deltoid and scapular stabilizers
will be permitted at 3 months post surgery.
