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Ruptured Anterior Cruciate LigamentNCT01348945

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

A study testing conventional ACL rehabilitation program in people with Ruptured Anterior Cruciate Ligament and Partial Tear Ligament, run by Chinese University of Hong Kong at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
conventional ACL rehabilitation program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
May 2011to Feb 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Physiotherapy Department, Prince of Wales Hospital, Shatin

    Hong Kong, 852

Other trials in China

About this study

Official title: Proprioceptive Function, Postural Stability & Clinical Outcome After Stump Preserving Anterior Cruciate Ligament Reconstruction Surgery - A Comparative Study

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.

Read the detailed description

Anterior cruciate ligament (ACL) is well known to be the knee's primary stabilizer which would be compromised by ligamentous injury, causing various functional deficits. Currently, ACL reconstruction is the common management focus on restoration of stability. Beside joint stabilization, proprioception, defined as the system of joint position sense and movement, is another function of the ACL which has also been widely studied.

The proprioceptive function of human ACL has been recognized since the 1980's. The first study by described the presence of mechanoreceptors in human ACL fibres. Study further proved that ACL is extensively innervated with neural elements.

Numerous studies reported ACL is rich in mechanoreceptors which contribute in proprioceptive function. One study on 29 ACL remnant reported that there are mechanoreceptors including Ruffini, Pacini receptors, Golgi tendon organ-like receptors and free nerves endings in the remnant and showed the numbers of mechanoreceptors is significantly related to joint sense accuracy. Another study performed by same group of researchers reported that a somatosensory evoked potential could be recorded in ACL remnants after electrical stimulation, confirmed original sensory neurons are preserved to certain extent, which may help graft neuralization and restoration of knee function. This further echos with various studies that, in ACL-deficit knee, loss of proprioceptive function is reported with corelation to the number of mechanoreceptors. At a result, it comes up with an idea that preserving the ACL remnant should help maintaining or facilitating proprioceptive function, by the operation technique of ACL augmentation.

ACL augmentation is a relatively new technique which preserves and augments the ACL remnant using extra graft. Under arthroscopic examination, if any of the ACL bundles, anteromedial (AM) and posterolateral (PL), shows a partial tear remnant of reasonable size, thickness and tension, augmentation may be performed instead of reconstruct the whole ligament. Instead of removing the remaining stump, it would be preserved as much as possible, and a formal ACL reconstruction would be performed. A commonly used graft is single-bundle autogenous semitendinosus gracilis tendon. As the retaining ACL fiber contains mechanoreceptor responsible for proprioception, it is believed that better knee proprioception and postural sense could be achieved by preserving the ACL remnant. Also, better vascularization and stronger mechanical protection is expected as native ACL fiber is retained.

The current management of partial tear ACL injury are mainly conservative treatment and surgical treatment, including reconstruction and augmentation. For augmentation, the common practise is to perform a "Selective Bundle Reconstruction", that is to reconstruct the torn bundle, either AM or PL reconstruction, and preserve the remaining intact one.

The clinical benefits of ACL augmentation had been reported by several studies. A study had demonstrated good clinical results in International Knee Documentation Commitee (IKDC) knee evaluation score, Cincinnati Knee Score and KT1000 in augmentation using autologous doubled and tripled semitendinosus (selective AM or PL) reconstruction at 1 year post-operatively.

An other comparison study between ACL augmentation (selective AM or PL reconstruction) and reconstruction showed superior result in knee anterior stability in clinical tests, KT2000 and knee joint position sense in augmentation group at a 2-year follow-up period. This study has demonstrated the post-operation comparison only and allogenic fascia lata graft was also used in the control reconstruction group, which is not a common graft to be used in ACL surgery in local setting. Moreover, as the assessment is performed at 2 years post-operatively, the more immediate and early post-operative effect of this surgical technique is still questionable.

As mentioned above, ACL augmentation may has potential clinical advantages including better knee stability, mechanical strength and proprioceptive function, yet evidence of the earlier effect of this technique is still lacking, with joint position sense was demonstrated by one study only. With the relatively new technique's popularity and potential benefit on proprioception, it deserves more research on studying the difference in both the clinical and proprioception outcome from reconstruction. Therefore, a comparative study on the difference in knee proprioception and postural stability between ACL augmentation and reconstruction, including early post-operative assessment is performed.

In local setting, if the ACL injury is noted to be partially torn from pre-operative Magnetic Resonance Imaging (MRI), surgeons would try to preserve the remaining stump as much as possible with a single bundle ACL reconstruction performed intra-operatively. In order to make the current study result meaningful and could be generalized in local setting, ACL augmentation is renamed as ACL stump-preserving surgery, which is the common practice in local setting.

Being tested
conventional ACL rehabilitation program
Keywords
Partial tear ACL, Stump preserved ACL surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • conventional ACL rehabilitation programOther

    Conventional post-operative physical therapy exercises and rehabilitation, designed for ACL reconstruction for 6 months to 9 months.

Study groups in NCT01348945
Study groupRoleWhat they receive
Stump Preserving ACL SurgeryExperimentalPatients of partial tear ACL injury fulfilling inclusion criteria received stump preserving ACL surgery, entered conventional ACL reconstruction rehabilitation program
Receives: Other: conventional ACL rehabilitation program
ACL ReconstructionActive comparatorPatients with complete tear ACL injury received ACL reconstruction entered conventional ACL rehabilitation program
Receives: Other: conventional ACL rehabilitation program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Joint Position Sense 1

    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

    Measured: Joint position sense at an expected average of 4 weeks before operation

  2. Joint Position Sense 2

    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

    Measured: Joint position sense at 1 month post-operation

  3. Joint Position Sense 3

    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

    Measured: Joint position sense at 3 month post-operation

  4. Joint Position Sense 4

    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

    Measured: Joint Position Sense at 6 months post-operation

  5. Joint Position Sense 5

    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

    Measured: Joint position sense at 1 year post-operation

  6. Postural Balance 1

    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

    Measured: Postural balance at an expected average of 4 weeks before operation

  7. Postural Balance 2

    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

    Measured: Postural balance at 1 month post-operation

  8. Postural Balance 3

    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

    Measured: Postural balance at 3 month post-operation

  9. Postural Balance 4

    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

    Measured: Postural balance at 6 month post-operation

  10. Postural Balance 5

    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

    Measured: Postural balance at 1 year post-operation

Secondary outcomes (4)
  1. Clinical Test 1

    Anterior Drawer Test, Lachman Test and Knee range of motion

    Measured: Test at an expected average of 4 weeks before operation

  2. Clinical Test 2

    Anterior Drawer Test, Lachman Test and Knee range of motion

    Measured: Post-operative 3 month

  3. Clinical Tests 3

    Anterior Drawer Test, Lachman Test and Knee range of motion

    Measured: Post-operative 6 month

  4. Clinical Tests 4

    Anterior Drawer Test, Lachman Test and Knee range of motion

    Measured: Post-operative 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2011 (estimated)
  4. Study completionFeb 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01348945
Sponsor's protocol ID
SPACL-CS
Status last verified
Dec 2010
First submitted
4 May 2011
Last updated
6 May 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing conventional ACL rehabilitation program in people with Ruptured Anterior Cruciate Ligament and Partial Tear Ligament, run by Chinese University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Joint Position Sense 1 (time frame: Joint position sense at an expected average of 4 weeks before operation). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2011; AzTrials last refreshed its copy on 30 Oct 2026.

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