Title: All-arthroscopic versus mini-open repair of small or moderate-sized rotator cuff tears (NCT00128076)

Investigators: J. MacDermid, J. Moro

Sponsor: CIHR

Summary: This randomized, multi-centre, national trial will determine whether an arthroscopic or mini-open repair provides better quality of life for patients with small or moderate-sized rotator cuff tears. The primary outcome measure is a valid quality-of-life scale (Western Ontario Rotator Cuff (WORC)) that addresses 5 domains of health affected by rotator cuff disease. Secondary outcomes will assess rotator cuff functionality (ROM, strength, Constant score), secondary dimensions of health (general health status (SF-12) and work limitations), and repair integrity (MRI). Outcomes are measured at baseline, at 6 weeks, 3, 6, 12, 18, and 24 months post-operatively by blinded research assistants and musculoskeletal radiologists. Patients (n=250) with small or medium-sized cuff tears identified by clinical examination and MRI who meet eligibility criteria will be recruited. Surgeons will participate in either conventional or expertise-based designs according to defined criteria to avoid biases from differential surgeon expertise. Mini-open or all-arthroscopic repair procedures will be performed according to a standardized protocol. Enrolment will require 2 years and follow-up an additional 2 years.

Status: Currently recruiting

Title: Health-Related Quality of Life (HRQoL) in Patients with Dupuytren's Disease: A Prospective Cohort Study (NCT00468949)

Investigators: A. Thoma

Sponsor: Surgical Associates Grant

Summary: The primary objective of this study is to measure the change in HRQL in Dupuytren's contracture patients who do and do not undergo palmar fasciectomy. Health related quality of life will be measured using the 1) Health Utilities Index Mark III (HUI3); 2) Short Form-36 (SF-36); and the 3) Michigan Hand Outcomes Questionnaire (MHQ). The secondary objective is to look at the measurement properties, including the reliability and responsiveness, of each of the three HRQL instruments when they are used in patients with Dupuytren's contracture. We will also assess the concurrent validity of each of the HRQL instruments.

Status: Currently recruiting

Title: The impact of waiting for carpal tunnel surgery

Investigators: C. Levis, J. MacDermid, J. Bain, N. Hynes, S. Mandel, J. Moro, K. Rajaratnam, A. Thoma

Sponsor: Surgical Associates Grant

Summary: The objectives of this study is to: 1) describe the impact on quality of life (QoL), cost, disability and lost-work time that accrues when patients referred for surgical care of carpal tunnel syndrome (CTS) wait for consultation and surgical intervention; 2) determine if the recovery of impairment and disability six months following carpal tunnel surgery is adversely affected by preoperative wait times; 3) determine which factors predict recovery and return to work after CTS surgery; 4) compare the SF-36, and 2 direct utility measures (EuroQol (EQ-5D) and Health Utilities Index 3 (HDI3)) in this population to identify the variations in utility attributable to instruments differences. Outcomes measures include sensibility testing, vascular/pain measures, self-reported upper extremity function, dexterity/functional ability, strength, work and quality of life surveys. Assessments are conducted at baseline and every 2 months until the surgery is performed. Follow-up visits will occur at 1, 2, 3, and 6 months after surgery.

Status: Recruiting

Title: Pregabalin vs placebo as an add on for complex regional pain syndrome (CRPS) of the upper limb managed by stellate ganglion block

Principal Investigator: Dr. Norman Buckley, Chair of Department of Anesthesia, McMaster University, Director Pain Management Centre, Hamilton Health Sciences

Co-Investigators: Dr. Susmita Ooomman, Consultant in Pain & Anaesthetics, Anaesthesia Department, Withybush General Hospital, Wales, UK

Dr. Ammar A. Gilani, Assistant Professor/Staff Neurologist, Department of Medicine/Neurology Section, McMaster University/Hamilton Health Sciences

Sponsor: Pfizer

This pilot study is a prospective randomized double blind placebo vs. pregabalin study.  Both men and non pregnant, non lactating women between the ages of 18-65 who are suffering from CRPS Type I of the upper limb who are currently managed with stellate ganglion block, with or without additional pharmacotherapy, will be included.  The patients will have baseline daily pain scores of 4/10 to be eligible to enter the study. 

Patients will be randomized to two groups with the placebo group comprising 10 patients and the pregabalin group comprising 20 patients.  The pregabalin arm will follow a flexible dosing schedule such that the doses will be titrated upward weekly, increasing until either pain scores improve or side-effects manifest.  If the patient reports improvement in the pain scores, no further increase in dose will occur and the patient will continue on the same dose until the end of the study.  If the patients report intolerable side effects then the dose will be titrated down to the previously tolerated dose and that dose will carry on to the end of the study.  The starting dose will be 75mg twice daily (BID), increasing the next week to 150mg BID then 300mg BID at the 3rd week; this is also the maximum dose.  Following the adjustment period of 2 to 5 weeks the drug maintenance period will continue from week 5 to 12.  Results will then be analyzed after 12 weeks.  For further information, please call: 905-527-4322 x. 44621 (fax: 905-577-8022).

Status: Recruiting

Title: A study design for examining the test retest reliability and concurrent construct validity of a new functional performance test for the shoulder – the FIT-HaNSA (Functional Impairment Test – Head, Neck, Shoulder and Arm)

Investigators: J. MacDermid

Sponsor: Unfunded

Summary: The purpose of this study is to examine the psychometric properties of a newly designed functional performance test called the FIT-HaNSA on patients with shoulder problems. Patients perform 3 repetitive arm tasks for up to 5 minutes (1) moving 1-kg containers between shelves at waist-height level and 25 cm above it; 2) moving 1-kg containers between shelves at eye-level and 25 cm below it; 3) manipulating bolts and screws in an overhead position); answer 2 questionnaires; and have their shoulder strength and range of motion measured on 2 occasions.

Status: Completed

Title: Survey of Fall and Injury Prevention Strategies used by Rehabilitation Professionals when Managing Distal Radius Fractures

Investigators: J. MacDermid

Sponsor: Unfunded

Summary: The purpose of this study is to determine the fall and injury prevention strategies used by rehabilitation professionals in their treatment of people with distal radius fractures. We are also investigating what rehabilitation clinicians perceive to be barriers to the implementation of fall and injury prevention strategies in this patient population. Participants are asked to answer an internet-based survey on their use of assessment areas and treatment practices for fall and injury prevention strategies in their clinical practice.

Status: Not yet recruiting