Arthroscopic Rotator Cuff Repair of Full Thickness Tears With and Without Arthroscopic Acromioplasty

• Sponsor: Panam Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00290888
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Duration (Months): 83
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

Surgical repair of full thickness tears of the rotator cuff is a controversial issue, with several procedures currently being used to treat the tear. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. However, an arthroscopic cuff repair without acromioplasty may offer the same degree of improvement as one that includes acromioplasty, but without threatening the shoulder stability that is provided by the acromion and coracoacromial ligament. This prospective study examines the hypothesis that appropriate shoulder function can be restored through the execution of the traditional arthroscopic cuff repair without acromioplasty.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear; Shoulder Impingement Syndrome	Procedure: Acromioplasty	N/A

Detailed Description

There exists some controversy in the current trend in repair of full thickness tears of the rotator cuff. The two most common treatments at this point in time are arthroscopic cuff repair with and without acromioplasty. The purpose of acromioplasty is to create adequate space for the rotator cuff tendons. Arthroscopic acromioplasty involves the removal of the subacromial bursa, resection of the coracoacromial ligament and anteroinferior portion of the acromion, and resection of any osteophytes from the acromioclavicular joint that are thought to be contributing to impingement. However, acromioplasty without cuff repair has been reported to have both good and poor results, showing that the technique may be suspect in repair of full thickness tears alone.

The purpose of this study is to compare the effectiveness of arthroscopic cuff repair with acromioplasty to arthroscopic cuff repair without acromioplasty in repair of full thickness tears of the rotator cuff.

We hypothesize that there will be a significant clinical improvement in quality of life in patients who receive a rotator cuff repair without acromioplasty compared to those who receive a cuff repair with acromioplasty.

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Arthroscopic Rotator Cuff Repair With and Without Arthroscopic Acromioplasty in the Treatment of Full Thickness Rotator Cuff
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ACR Arthroscopic rotator cuff repair without acromioplasty	Procedure: Acromioplasty
Experimental: ACR-A Arthorscopic rotator cuff repair with acromioplasty	Procedure: Acromioplasty

Outcome Measures

Primary Outcome Measures

1. Western Ontario Rotator Cuff Index (WORC) [24 months]

   Calculated as percentage with an increase in score indicating an improvement in outcome.

2. American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES) [24 months]

   Calculated as a percentage with an increase in score reflecting an improvement in outcome.

Secondary Outcome Measures

1. Shoulder Range of Motion [24 months]

2. Upper Extremity Strength Grading [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ages 18 or older

• Complete rotator cuff tear up to 4 cm in size

• Persistent pain and functional disability for at least 6 months

• Failure of conservative treatment

• Establishment of final eligibility based upon visual exam of rotator cuff tear during surgery and determination of repairability

Exclusion Criteria:

• Evidence of significant osteoarthritis or cartilage damage in the shoulder

• Evidence of glenohumeral instability including Bankart lesions and labral tears of any type

• Previous surgeries of the shoulder

• Evidence of major joint trauma, infection, or necrosis in the shoulder

• Patients with partial thickness tears of the rotator cuff

• Patients unable to provide informed consent due to language barrier or mental status

• Patients with a major medical condition that would affect quality of life and influence the results of the study

• Patients with worker compensation claims

• Patients unwilling to be followed for the duration of the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Panam Clinic	Winnipeg	Manitoba	Canada	R3M 3E4

Sponsors and Collaborators

• Panam Clinic

Investigators

• Principal Investigator: Peter MacDonald, MD, FRCS(C), Panam Clinic Orthopedics and Sports Medicine/University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

• Baker CL, Liu SH. Comparison of open and arthroscopically assisted rotator cuff repairs. Am J Sports Med. 1995 Jan-Feb;23(1):99-104.
• Bokor DJ, Hawkins RJ, Huckell GH, Angelo RL, Schickendantz MS. Results of nonoperative management of full-thickness tears of the rotator cuff. Clin Orthop Relat Res. 1993 Sep;(294):103-10.
• Budoff JE, Nirschl RP, Guidi EJ. Débridement of partial-thickness tears of the rotator cuff without acromioplasty. Long-term follow-up and review of the literature. J Bone Joint Surg Am. 1998 May;80(5):733-48. Review.
• Cofield RH. Rotator cuff disease of the shoulder. J Bone Joint Surg Am. 1985 Jul;67(6):974-9.
• Ellman H, Kay SP, Wirth M. Arthroscopic treatment of full-thickness rotator cuff tears: 2- to 7-year follow-up study. Arthroscopy. 1993;9(2):195-200.
• Esch JC. Arthroscopic subacromial decompression and postoperative management. Orthop Clin North Am. 1993 Jan;24(1):161-71. Review.
• Gartsman GM, Taverna E. The incidence of glenohumeral joint abnormalities associated with full-thickness, reparable rotator cuff tears. Arthroscopy. 1997 Aug;13(4):450-5.
• Gartsman GM. Arthroscopic assessment of rotator cuff tear reparability. Arthroscopy. 1996 Oct;12(5):546-9.
• Kirkley A, Griffin S, McLintock H, Ng L. The development and evaluation of a disease-specific quality of life measurement tool for shoulder instability. The Western Ontario Shoulder Instability Index (WOSI). Am J Sports Med. 1998 Nov-Dec;26(6):764-72.
• Levy HJ, Gardner RD, Lemak LJ. Arthroscopic subacromial decompression in the treatment of full-thickness rotator cuff tears. Arthroscopy. 1991;7(1):8-13.
• Miller C, Savoie FH. Glenohumeral abnormalities associated with full-thickness tears of the rotator cuff. Orthop Rev. 1994 Feb;23(2):159-62.
• Neer CS 2nd. Anterior acromioplasty for the chronic impingement syndrome in the shoulder: a preliminary report. J Bone Joint Surg Am. 1972 Jan;54(1):41-50.

• Responsible Party: Peter MacDonald, Department Head, Orthopaedics, Panam Clinic
• ClinicalTrials.gov Identifier: NCT00290888
• Other Study ID Numbers: B2004:045
• First Posted: Feb 13, 2006
• Last Update Posted: Mar 27, 2015
• Last Verified: Mar 1, 2015

• Keywords provided by Peter MacDonald, Department Head, Orthopaedics, Panam Clinic: Rotator Cuff Tear; Tendon Repair; Acromioplasty; Arthroscopy; Orthopedic Surgery
• Additional relevant MeSH terms: Shoulder Impingement Syndrome; Rotator Cuff Injuries

Study Results

Participant Flow

Recruitment Details	A total of 86 patients were randomized to either ACR-A or ACR

Arm/Group Title	Arthroscopic Rotator Cuff Repair Without Acromioplasty	Arthorscopic Rotator Cuff Repair With Acromioplasty
Arm/Group Description	ACR Acromioplasty	ACR-A Acromioplasty
Period Title: Overall Study
STARTED	41	45
COMPLETED	38	44
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Arthroscopic Rotator Cuff Repair Without Acromioplasty	Arthroscopic Rotator Cuff Repair With Acromioplasty	Total
Arm/Group Description	Arthroscopic rotator cuff repair without acromioplasty (ACR)	Arthroscopic rotator cuff repair with acromioplasty (ACR-A)	Total of all reporting groups
Overall Participants	41	45	86
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.1 (9.5)	56.2 (7.9)	56.7 (8.7)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	41 100%	45 100%	86 100%
>=65 years	0 0%	0 0%	0 0%
Gender (participants) [Number]
Female	15 36.6%	14 31.1%	29 33.7%
Male	30 73.2%	24 53.3%	54 62.8%
Region of Enrollment (participants) [Number]
Canada	41 100%	45 100%	86 100%

Outcome Measures

1. Primary Outcome

Title	Western Ontario Rotator Cuff Index (WORC)
Description	Calculated as percentage with an increase in score indicating an improvement in outcome.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arthroscopic Rotator Cuff Repair Without Acromioplasty	Arthroscopic Rotator Cuff Repair With Acromioplasty
Arm/Group Description	ACR	ACR-A Acromioplasty
Measure Participants	38	44
Mean (Standard Deviation) [percentage of total score]	80.5 (22.3)	86.7 (16.2)

2. Primary Outcome

Title	American Shoulder and Elbow Surgeons Standardized Form for the Assessment of the Shoulder (ASES)
Description	Calculated as a percentage with an increase in score reflecting an improvement in outcome.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arthroscopic Rotator Cuff Repair Without Acromioplasty	Arthorscopic Rotator Cuff Repair With Acromioplasty
Arm/Group Description	ACR	ACR-A Acromioplasty
Measure Participants	38	44
Mean (Standard Deviation) [percentage of total score]	84.6 (20.1)	89.8 (14.4)

3. Secondary Outcome

Title	Shoulder Range of Motion
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Upper Extremity Strength Grading
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Arthroscopic Rotator Cuff Repair Without Acromioplasty		Arthroscopic Rotator Cuff Repair With Acromioplasty
Arm/Group Description	ACR		ACR-A Acromioplasty
All Cause Mortality
	Arthroscopic Rotator Cuff Repair Without Acromioplasty		Arthroscopic Rotator Cuff Repair With Acromioplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arthroscopic Rotator Cuff Repair Without Acromioplasty		Arthroscopic Rotator Cuff Repair With Acromioplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Arthroscopic Rotator Cuff Repair Without Acromioplasty		Arthroscopic Rotator Cuff Repair With Acromioplasty
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/45 (0%)

Limitations/Caveats

Variation in surgical technique and post-op rehabilitation. We do not have confirmation of cuff healing status as no imaging was carried out post-operatively. Assessment of AC morphology is subjective & based solely on pre-operative radiographs.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.