Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001202853
Ethics application status
Approved
Date submitted
19/09/2012
Date registered
15/11/2012
Date last updated
15/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is there a relationship between impingement in the hip and tearing of the hamstring tendon near the buttock.
Scientific title
The relationship between proximal avulsion of common hamstrings tendon and/or hamstring tendinopathy and femoroacetabular impingement
Secondary ID [1] 281274 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hamstring avulsion 287417 0
Femoroacetabular impingement (FAI) 287787 0
Condition category
Condition code
Musculoskeletal 287751 287751 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will retrospectively review patients who suffered from hamstring problems and try and correlate these with FAI. We suspect these two entities are commonly being confused by
mistake.

The duration of the observation is approximately 6-12 months.
Intervention code [1] 285696 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288024 0
the validated scoring clinical tools of the WOMAC hip score, Mahorn Hip Outcome Tool (MHOT) and the Non-arthritic hip score will provide functional quantitative data. Total assessment of clinical signs and symptoms will also be analysed. This will allow for a greater proportion of qualitative analysis, combined with the quantitative data collected via the validated questionnaires.
Timepoint [1] 288024 0
Retrospective data- over the past 8 years
Secondary outcome [1] 299298 0
nil
Timepoint [1] 299298 0
nil

Eligibility
Key inclusion criteria
a. patients suffering/or suffered from hamstring pathology, with an age range between 18-50
b. Healthy patients undergoing hip Arthroscopy due to Cam or mixed FAI
c. No major OA changes according to XR and surgery observation (Tonnis 0-1)
d. No previous hip surgery
e. No other influential disabilities in lower limbs
f. No chronic use of NSAID, analgesics, steroids or chemotherapy drugs
g. Base line activity level - Tegner 3 and above
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a. Patients with concomitant disease, that may affect joints
b. Patients with major ligamentous laxity
c. Patients which have undergone only minor vertical capsulotomy (pincer only
lesions)
d. Patients with extreme ROM needs (such as ballet dancers)
e. Patients suffering from connective tissue disease
f. Patients suffering from bilateral symptomatic FAI operated for their first hip
g. Patients with relative or proved displastic hip determined by CE angle and/or
extreme version abnormalities as measured on apical CT/MR cuts and pelvic XR
h. Adjuvant required surgical procedure to common cam FAI surgery (such as IP
release)
i. Patients whom their cartilage hip status was define as advanced OA, during surgery,
or patients which, following surgery, would be instructed to avoid full weight
bearing on the operated hip for more than 4 weeks
j. Concomitant use of PRP or TA during the surgical procedure

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286006 0
Self funded/Unfunded
Name [1] 286006 0
Dr David Young
Country [1] 286006 0
Australia
Primary sponsor type
Individual
Name
Dr David Young
Address
33 The Avenue
Windsor 3181 VIC
Country
Australia
Secondary sponsor category [1] 284826 0
Individual
Name [1] 284826 0
Dr Brett Moreira
Address [1] 284826 0
33 The Avenue
Windsor 3181 VIC
Country [1] 284826 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288054 0
The Avenue Hospital Ethics Committee
Ethics committee address [1] 288054 0
The Avenue Hospital
40 The Avenue
Windsor VIC 3181
Ethics committee country [1] 288054 0
Australia
Date submitted for ethics approval [1] 288054 0
Approval date [1] 288054 0
21/05/2012
Ethics approval number [1] 288054 0
Trial 133 -The relationship between proximal avulsion of common hamstrings tendon and/or hamstring tendinopathy and femoracetabular impingement

Summary
Brief summary
Hamstring avulsion is a common misdiagnosis for FAI and there appears to be a relationship between these two diagnoses. This relationship has never been studied. This study could contribute significantly to the global understanding of this hard to treat entity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34711 0
Address 34711 0
Country 34711 0
Phone 34711 0
Fax 34711 0
Email 34711 0
Contact person for public queries
Name 17958 0
Dr Brett Moreira
Address 17958 0
33 The Avenue
Windsor 3181 VIC
Country 17958 0
Australia
Phone 17958 0
+61 402344463
Fax 17958 0
Email 17958 0
[email protected]
Contact person for scientific queries
Name 8886 0
Dr Brett Moreira
Address 8886 0
33 The Avenue
Windsor 3181 VIC
Country 8886 0
Australia
Phone 8886 0
+61 402344463
Fax 8886 0
Email 8886 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.