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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01348945 |
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Date of registration:
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04/05/2011 |
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Primary sponsor: |
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Public title:
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Proprioceptive Function, Postural Stability & Clinical Outcome After Stump Preserving Anterior Cruciate Ligament Reconstruction Surgery
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Scientific title:
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Proprioceptive Function, Postural Stability & Clinical Outcome After Stump Preserving Anterior Cruciate Ligament Reconstruction Surgery - A Comparative Study |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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48 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01348945 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
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Countries of recruitment
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China
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Contacts
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Name:
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Holly KH Leung |
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Address:
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Telephone:
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Email:
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Affiliation:
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Physiotherapy Department, Prince of Wales Hospital, Shatin, Hong Kong |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- for stump reserving group: partial tear ACL injury with remnant of sizable,
reasonable thickness and tension suitable
- for ACL reconstruction group: complete tear ACL injury
- for both groups: no complication such as wound infection after operation
- no history of medical problems, for example, heart disease
Exclusion Criteria:
- concomitant Medial Collateral Ligament (MCL), Lateral Collateral Ligament (LCL),
Posterior Cruciate Ligament (PCL) injury, meniscus tear on the relevant knee
- previous or concomitant surgery on the relevant knee and other joints
- surgery or traumatic injuries to the contralateral limb
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Partial Tear Ligament
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Ruptured Anterior Cruciate Ligament
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Intervention(s)
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Other: conventional ACL rehabilitation program
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Primary Outcome(s)
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Joint Position Sense 1
[Time Frame: Joint position sense at an expected average of 4 weeks before operation]
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Joint Position Sense 2
[Time Frame: Joint position sense at 1 month post-operation]
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Joint Position Sense 3
[Time Frame: Joint position sense at 3 month post-operation]
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Joint Position Sense 4
[Time Frame: Joint Position Sense at 6 months post-operation]
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Joint Position Sense 5
[Time Frame: Joint position sense at 1 year post-operation]
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Postural Balance 1
[Time Frame: Postural balance at an expected average of 4 weeks before operation]
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Postural Balance 2
[Time Frame: Postural balance at 1 month post-operation]
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Postural Balance 3
[Time Frame: Postural balance at 3 month post-operation]
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Postural Balance 4
[Time Frame: Postural balance at 6 month post-operation]
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Postural Balance 5
[Time Frame: Postural balance at 1 year post-operation]
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Secondary Outcome(s)
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Clinical Test 1
[Time Frame: Test at an expected average of 4 weeks before operation]
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Clinical Test 2
[Time Frame: Post-operative 3 month]
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Clinical Tests 3
[Time Frame: Post-operative 6 month]
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Clinical Tests 4
[Time Frame: Post-operative 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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