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Proprioceptive Function, Postural Stability & Clinical Outcome After Stump Preserving Anterior Cruciate Ligament Reconstruction Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Chinese University of Hong Kong.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01348945
First received: May 4, 2011
Last updated: May 5, 2011
Last verified: December 2010
History of Changes
  Purpose

Anterior cruciate ligament (ACL) is known to serve a number of functions in the knee joint. Besides providing mechanical stability, it also contributes to proprioceptive function. Numerous studies reported ACL is rich in mechanoreceptors contribute in proprioceptive function. ACL augmentation, or selective ACL bundle (AM, anteromedial or PL, posterolateral) reconstruction, a relatively new technique for partial torn ACL, preserves and augments the ACL remnant aiming at maintaining or facilitating proprioception, is now gaining its popularity. Preserving ACL stump is also reported to have merits in providing better mechanical protection and promoting revascularization to the newly reconstructed graft.

In local setting, stump preserving ACL surgery is the usual practice in handling partial ACL tear. With the background of the surgery's potential benefits in restoration of knee function, a single-blinded, comparative study on the difference in proprioception, postural stability and clinical outcome between stump preserving ACL surgery and reconstruction is conducted.


Condition Intervention
Ruptured Anterior Cruciate Ligament
Partial Tear Ligament
 Other: conventional ACL rehabilitation program

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Proprioceptive Function, Postural Stability & Clinical Outcome After Stump Preserving Anterior Cruciate Ligament Reconstruction Surgery - A Comparative Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Joint Position Sense 1 [ Time Frame: Joint position sense at an expected average of 4 weeks before operation ] [ Designated as safety issue: Yes ]
    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

  • Joint Position Sense 2 [ Time Frame: Joint position sense at 1 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

  • Joint Position Sense 3 [ Time Frame: Joint position sense at 3 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

  • Joint Position Sense 4 [ Time Frame: Joint Position Sense at 6 months post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

  • Joint Position Sense 5 [ Time Frame: Joint position sense at 1 year post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

  • Postural Balance 1 [ Time Frame: Postural balance at an expected average of 4 weeks before operation ] [ Designated as safety issue: Yes ]
    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

  • Postural Balance 2 [ Time Frame: Postural balance at 1 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

  • Postural Balance 3 [ Time Frame: Postural balance at 3 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

  • Postural Balance 4 [ Time Frame: Postural balance at 6 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

  • Postural Balance 5 [ Time Frame: Postural balance at 1 year post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement


Secondary Outcome Measures:
  • Clinical Test 1 [ Time Frame: Test at an expected average of 4 weeks before operation ] [ Designated as safety issue: Yes ]
    Anterior Drawer Test, Lachman Test and Knee range of motion

  • Clinical Test 2 [ Time Frame: Post-operative 3 month ] [ Designated as safety issue: Yes ]
    Anterior Drawer Test, Lachman Test and Knee range of motion

  • Clinical Tests 3 [ Time Frame: Post-operative 6 month ] [ Designated as safety issue: Yes ]
    Anterior Drawer Test, Lachman Test and Knee range of motion

  • Clinical Tests 4 [ Time Frame: Post-operative 1 year ] [ Designated as safety issue: Yes ]
    Anterior Drawer Test, Lachman Test and Knee range of motion


Estimated Enrollment: 48
Study Start Date: May 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stump Preserving ACL Surgery
Patients of partial tear ACL injury fulfilling inclusion criteria received stump preserving ACL surgery, entered conventional ACL reconstruction rehabilitation program
 Other: conventional ACL rehabilitation program
Conventional post-operative physical therapy exercises and rehabilitation, designed for ACL reconstruction for 6 months to 9 months.
Active Comparator: ACL Reconstruction
Patients with complete tear ACL injury received ACL reconstruction entered conventional ACL rehabilitation program
 Other: conventional ACL rehabilitation program
Conventional post-operative physical therapy exercises and rehabilitation, designed for ACL reconstruction for 6 months to 9 months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348945

Locations
China
Physiotherapy Department, Prince of Wales Hospital, Shatin
Hong Kong, China, 852
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Holly KH Leung Physiotherapy Department, Prince of Wales Hospital, Shatin, Hong Kong
  More Information

No publications provided

Responsible Party: Holly Leung King Ho, Physiotherapy Department of Prince of Wales Hospital
ClinicalTrials.gov Identifier: NCT01348945     History of Changes
Other Study ID Numbers: SPACL-CS
Study First Received: May 4, 2011
Last Updated: May 5, 2011
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Partial tear ACL
Stump preserved ACL surgery

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013