Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0227186094
Study information
Scientific title
Acronym
Study hypothesis
What is the effect of concomitant biceps tenodesis in primary shoulder arthroplasty done for primary osteoarthritis? Does it improve or worsen the pain relief and function of the new shoulder joint or it has no effect? This project aims to produce a level I evidence for this question at 2 and 5 years follow up.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Musculoskeletal Diseases: Osteoarthritis
Intervention
DESIGN OF STUDY - This is a prospective randomised controlled study recruiting patients who have been wait listed for primary shoulder replacement operation for primary shoulder osteoarthrosis at JCUH. These patients will be given all the information about the study at least 2 weeks prior to operation and those patients willing to participate in the study will be consented and recruited into the study.
PILOT STUDY - Since the surgeon is experienced and has been performing biceps tenodesis in addition to shoulder replacement operations in certain selected cases, the pilot study has not been planned.
TRIAL PHASE - Once the trial phase begins all the patients who are listed as candidates for primary shoulder operation for Primary Osteoarthritis are assessed by an independent observer in the clinic. The patients are given information leaflet about the condition he or she has got, about the study being performed and blinded allocation of patients into two groups "with or without concomitant biceps tenodesis at the time of Primary shoulder replacement operation". Any questions from the patients will also be clarified. Address and telephone number for further help and information is also given in the information leaflet. For selecting the surgical procedure, a blinded randomisation will be performed using the SPSS soft ware (SPSS, Chicago, IL). The code of the procedure (1. Concomitant Biceps tenodesis 2. No concomitant biceps tenodesis) will be revealed to surgeon at the time of operation. The anaesthesia, surgical approach, post operative pain management and rehabilitation will be exactly same between both groups. A standardised prostair is used in all cases. Tenodesis of long head of biceps is only an additional step, where in the tendon will be divided and sutured into its bony tunnel, around its sheath by means of 2-3 interrupted non absorbable sutures. This step of operation needs no additional exposure of the wound nor it takes longer than 3-4 mins when performed. Patients and the single independent observer will be blinded as to the procedure performed until the end of the study. Patients are followed up at 6 weeks, 3 months, 6 months post op and yearly thereafter. All the clinical and radiographic data documented in a specifically designed data collection form. Data will be regularly entered into spread sheets using SPSS software. Analysis of the various demographic, functional and radiological data including Oxford and Constant scores will be done at 1 year, 2 years, 5 years follow up.
SURGEONS PERFORMING THE PROCEDURES - The number of surgeons performing to the procedure will be limited to 2-3 over the study period and all operations will be performed in the presence of a senior consultant orthopaedic surgeon at JCUH.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
During the pre op and various stages of post operative phases, demographic details will be collected. A patient questionnaire (based on Oxford score) which will give information about pain and functional abilities.Assessment using Constant and Murley score which looks at assessment of daily activities (score), assessment of external rotation and internal rotation (score for each movement), assessment of forward elevation and lateral elevation (score for various degrees of movement), pain level (scored 0, 5, 10, 15), level of raising the hand (up to waist, xiphoid, neck, up to the head, above the head, unable to move shoulder), shoulder power (measured by a special device).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2006
Overall trial end date
01/02/2011
Reason abandoned
Eligibility
Participant inclusion criteria
The study intends to examine all the patients with painful, primary degenerative glenohumeral joint who are listed to undergo a Primary Shoulder Replacement. It would involve patients from both sexes and all age groups. We have not sought for any statistical help yet for calculating the required sample size. It is expected to include at least 25 patients from each of the two operation groups. Statistical consultation has been requested.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
1. Patients with rheumatoid or other inflammatory arthritis
2. Patients who had previous operations for trauma or infection in the same joint
3. Neurovascular problems
4. Revision operations
5. Patients with history of previous instability problems of the shoulder
6. Patients with rotator cuff deficiency
7. Patients with previous biceps tendon rupture
8. However, the patient or assessor would be kept blind to whether concomitant biceps tenodesis procedure is performed.
Recruitment start date
01/02/2006
Recruitment end date
01/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Orthopaedics
Middlesbrough
TS5 5AZ
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Tees Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary