Can Shoulder Arthroscopy Work

NACompletedINTERVENTIONAL
Enrollment

313

Participants

Timeline

Start Date

September 14, 2012

Primary Completion Date

December 15, 2015

Study Completion Date

July 27, 2016

Conditions
Shoulder Impingement Syndrome
Interventions
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.

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

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.

Trial Locations (1)

OX3 7LD

Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, Oxford

All Listed Sponsors
collaborator

Arthritis Research UK

OTHER

collaborator

University of Aberdeen

OTHER

lead

University of Oxford

OTHER

NCT01623011 - Can Shoulder Arthroscopy Work | Biotech Hunter | Biotech Hunter