Can Shoulder Arthroscopy Work (CSAW)
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|ClinicalTrials.gov Identifier: NCT01623011|
Recruitment Status : Completed
First Posted : June 19, 2012
Last Update Posted : November 13, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Shoulder Impingement Syndrome||Procedure: Arthroscopic Sub-acromial Decompression Surgery Procedure: Shoulder Arthroscopy Other: Active Monitoring with Specialist Reassessment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||What is the Clinical and Cost Effectiveness of Arthroscopic Sub-acromial Decompression Surgery?|
|Actual Study Start Date :||September 14, 2012|
|Actual Primary Completion Date :||December 15, 2015|
|Actual Study Completion Date :||July 27, 2016|
Experimental: Arthroscopic Sub-acromial Decompression
Arthroscopic sub-acromial decompression surgery.
Procedure: Arthroscopic Sub-acromial Decompression Surgery
The procedure involves insertion of the arthroscope into the glenohumeral joint where the joint surface is inspected along with the intra-articular portion of the long head of biceps and the joint surface of the rotator cuff tendons. The arthroscope is then inserted into the sub-acromial bursa which lies outside the rotator cuff tendons and beneath the acromion process of the scapula. In the bursa the acromion and superior surface of the rotator cuff are assessed to ensure the coracoacromial ligament and the AC joint remains intact. The projecting under surface of the distal part of the acromion is resected.
Other Name: ASAD
Active Comparator: Shoulder Arthroscopy
Shoulder arthroscopy only.
Procedure: Shoulder Arthroscopy
This is the surgical comparison group. The procedure is performed under general anaesthetic. Patients will undergo a routine investigational arthroscopy. The operation will be performed in exactly the same manner as Group ASAD. The exception is they will not undergo the decompression (bone spur removal). Tissues will be visualised and the joint will be washed out. The time spent in theatre will be similar to that for Group ASAD. These measures provide the AO group with the characteristics necessary to provide a reasonable comparison and account for the placebo effects of surgery.
Other Name: Arthroscopy alone
Active Monitoring with Specialist Reassessment
Active monitoring with specialist reassessment - non-operative control.
Other: Active Monitoring with Specialist Reassessment
Patients will be advised that they will undergo active monitoring in the short term. They will attend a reassessment appointment 3 months after entering the study. Here, they will be asked to complete questionnaires related to their shoulder pain and undergo a clinical assessment for their shoulder. From an ethical standpoint it is emphasised that it is quite within normal practice to have a period of active monitoring.
- Oxford Shoulder Score [ Time Frame: 6 months post randomisation ]Patient reported outcome measure of shoulder pain and function.
- Oxford Shoulder Score [ Time Frame: 12 months post randomisation ]Patient reported outcome measure of shoulder pain and function
- Constant Murley Shoulder Score [ Time Frame: 6 and 12 months post randomisation ]Clinical assessment of the shoulder
- Pain DeTECT [ Time Frame: 6 and 12 months post randomisation ]Patient reported outcome related to neuropathic pain
- Quantitative Sensory Testing [ Time Frame: 6 and 12 months post randomisation ]Clinical assessment of pain and pain thresholds
- Health Economics - EQ5D [ Time Frame: 6 and 12 months post randomisation ]Patient reported expenditure and quality of life questions
- Complications [ Time Frame: 6 and 12 months post randomisation ]Patient reported complications post randomisation
- Treatment Expectations and Satisfaction [ Time Frame: 6 and 12 months post randomisation ]Patient reported questions on treatment expectations and satisfaction with treatment.
- Hospital Anxiety and Depression Scale [ Time Frame: 6 and 12 months post randomisation ]Patient reported questionnaire related to their feelings of anxiety and depression.
- Patient Response Shift [ Time Frame: 12 months post randomisation ]patient response shift on perceived disability will be assessed by comparing each patients pre-operative self-evaluation of their disability (baseline Oxford Shoulder Score) with a 12 month evaluation of their perceived pre-intervention state (the "thentest") according to the method of Razmjou et al (2010. This will give an indication of whether patients with sub-acromial pain underrate or overrate their pre-intervention disability according to their outcome.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||35 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Sub-acromial pain of at least 3 month (tendinopathy and partial tear only).
- Diagnosed by a Consultant of tendinopathic pain or partial thickness rotator cuff tear
- Has had an MRI or Ultrasound Scan to rule out alternative pathology
- Eligible for surgery.
Completed a conservative management programme previously including:
- physiotherapy that includes a remedial exercise regimen and
- at least x1 cortisone injection but not more than 3 injections.
- Full thickness tear of the rotator cuff tendons evident on MRI or Ultrasound imaging
- Undergone previous surgery on affected shoulder
- Have RA or other inflammatory disorder
- Symptomatic cervical spine pathology
- Previous septic arthritis
- History of radiotherapy on same side as affected shoulder
- Patients who have a strong preference for one treatment over another to an extent that they would not participate if allocated to their non- preferred group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623011
|Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences|
|Oxford, Oxfordshire, United Kingdom, OX3 7LD|
|Study Chair:||David J Beard, Professor||University of Oxford|
|Study Chair:||Andrew J Carr, Professor||University of Oxford|
|Principal Investigator:||Jonathan Rees||University of Oxford|
|Principal Investigator:||Jonathan Cook||University of Aberdeen|
|Principal Investigator:||Irene Tracey||University of Oxford|
|Principal Investigator:||Steven Gwilym||University of Oxford|
|Principal Investigator:||Cushla Cooper||University of Oxford|
|Responsible Party:||University of Oxford|
|Other Study ID Numbers:||
|First Posted:||June 19, 2012 Key Record Dates|
|Last Update Posted:||November 13, 2017|
|Last Verified:||November 2017|
Shoulder Impingement Syndrome
Wounds and Injuries