Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000997358
Ethics application status
Approved
Date submitted
21/06/2017
Date registered
11/07/2017
Date last updated
16/01/2019
Date data sharing statement initially provided
16/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Objective and subjective assessment of readiness to Return to Sport post Anterior Cruciate Ligament (ACL) reconstruction.
Scientific title
Subjective assessment of knee function and readiness to Return to Sport, versus objective muscle strength asymmetry 6 and 10 months post Anterior Cruciate Ligament Reconstruction
Secondary ID [1] 292245 0
None
Universal Trial Number (UTN)
U1111-1198-1867
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Reconstruction 303747 0
Condition category
Condition code
Injuries and Accidents 303120 303120 0 0
Other injuries and accidents
Musculoskeletal 303121 303121 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Anterior Cruciate Ligament Reconstruction (ACLR)

The ACLR will be performed using a medial portal femoral tunnel approach.
A hamstring autograft will be harvested from either ipsilateral or contralateral side and fixed in the femoral tunnel using an endobutton, and within the tibial tunnel using an intracortical tibial screw, plus/minus a staple, as necessary. Patients will be recruited for study participation 3 months post ACLR, and as such the ACLR is not conducted as part of this study.

The aim of this study is to investigate the correlation between an objective measure of quadriceps and hamstring isometric muscle strength (LSI) and subjective assessment of knee joint function and perceived readiness to Return to Sport (RTS) at 6 months and 10 months post ACLR.
Intervention code [1] 298411 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302499 0
Isometric muscle strength of both the quadriceps and hamstring, measured by Limb Symmetry Index.
Timepoint [1] 302499 0
6 months and 10 months post ACLR
Primary outcome [2] 302500 0
Self-reported knee function measured by the International Knee Documentation Committee (IKDC) 2000 Subjective Knee Form
Timepoint [2] 302500 0
6 months and 10 months post ACLR.
Primary outcome [3] 302501 0
Psychological readiness to Return to Sport assessed using the ACL – Return to Sport after Injury (ACL – RSI) Scale
Timepoint [3] 302501 0
6 and 10 months post ACLR.
Secondary outcome [1] 336239 0
Change in isometric muscle strength of both the quadriceps and hamstring, measured using an isokinetic dynamometre
Timepoint [1] 336239 0
change in time from 6 to 10 months post ACLR.

Eligibility
Key inclusion criteria
1. Patient has provided written, informed consent and is willing to participant;
2. Patient is prior to 6 months post ACLR following isolated rupture of the ACL;
3. Patient regularly participates in a Level 1 or Level 2 Activity level sports*;
4. Male and/or female patients of 14 years of age or greater.

*Activity Levels are defined by those outlined by Hefti et al. 1993. Levels 1 and 2 will be sub-classified to whether the athlete competed at elite (professional) level, or non-elite level sport.
- Level 1: Jumping, pivoting, hard cutting, football, soccer;
o Level 1A: Competing at an elite, professional sporting level
o Level 1B: Not competing in an elite, professional sporting level
- Level 2: Heavy manual work, skiing, tennis;
o Level 1A: Competing at an elite, professional sporting level
o Level 1B: Not competing in an elite, professional sporting level
- Level 3: Light manual work, jogging, running;
- Level 4: Sedentary work (ADL)


Reference: Hefti F, Muller W, Jakob RP, Staubli HU. Evaluation of knee ligament injuries with the IKDC form. Knee Surg Sports Traumatol Arthrosc. 1993;1(3-4):226-34.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient having undergone Revision ACLR.
2. Patients with a multi-ligament knee injury.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample Size:

Consecutive recruitment will occur over a 6 month period. All patients of whom have undergone an ACLR performed by a single surgeon will be invited to participant in the study. A sample size of 40 patients is estimated, which is an equivalent sample size used by Muller U, et al. 2015 to address similar objectives.

The sample size has been estimated within the limitations of cost and time availability. A post hoc power analysis will be conducted, and effect sizes reported.

Data Analysis:

Primary Objectives:
1. To determine whether quadriceps and hamstring isometric muscle strength measured by Limb Symmetry Index correlates with self-reported function and psychological readiness to RTS measured by the IKDC and ACL-RSI, at 6 months and 10 months post ACLR.
2. To determine how the association between muscle strength and self-reported function and psychological readiness to RTS changed time (6 to 10 months).

To address Objectives 1 and 2, a Pearson’s correlation coefficient will be calculated, conditional on distributions of both objective (LSI) and subjective (IKDC and ACL-RSI) measures.

3. To determine whether self-reported function and psychological readiness to RTS change, following knowledge of a ‘good’ muscle strength outcome (LSI of = 90.0%), and awareness of personal muscle strength results at 6 and 10 months post ACLR.

A Mixed ANOVA with two within factors including time (2 levels: Time 1 (6 months) and Time 2 (10 months)) and Pre-Post knowledge of muscle strength (2 levels), in addition to a between factor of nature of clinical outcome (3 levels). The established threshold is greater than or equal to 90% LSI, and the 3 levels include the following:
1. Positive LSI results exceeding threshold on both Time 1 and Time 2;
2. Negative LSI results below the threshold on Time 1 and Time 2;
3. Negative LSI results below the threshold for Time 1 but positive LSI results exceeding threshold for Time 2.

Secondary Objectives:
1. To determine if there is an improvement in muscle strength over time, from 6 to 10 months post ACLR.
2. To determine whether patients that require a 4-strand double hamstring autograft experience poorer muscle strength at 6 and 10 months post ACLR, compared with patients whom received a 4-strand single hamstring autograft.

Outcomes of LSI between patients that received a double versus single hamstring autograft will be assessed using a Mixed ANOVA with the within factor of time (6 Months and 10 months) and between factor of graft type.

In the event that study data produced results in a violation of the proposed test assumptions, alternative non-parametric equivalence will be utilised.

Reference:
Muller U, Kruger-Franke M, Schmidt M, Rosemeyer B. Predictive parameters for return to pre-injury level of sport 6 months following anterior cruciate ligament reconstruction surgery. Knee Surg Sports Traumatol Arthrosc. 2015;23(12):3623-31.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/07/2017
Date of last participant enrolment
Anticipated
5/01/2018
Actual
4/04/2018
Date of last data collection
Anticipated
5/08/2018
Actual
22/10/2018
Sample size
Target
40
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 296793 0
Self funded/Unfunded
Name [1] 296793 0
Country [1] 296793 0
Primary sponsor type
Individual
Name
Dr Matthew Liptak
Address
Flinders Private Hospital, Ground Floor,
1 Flinders Drive,
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 295777 0
Other Collaborative groups
Name [1] 295777 0
The International Musculoskeletal Research Institute Incorporated
Address [1] 295777 0
The International Musculoskeletal Research Institute Incorporated
13 Laffers Rd,
Belair, SA 5052
Country [1] 295777 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298027 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 298027 0
Ethics committee country [1] 298027 0
Australia
Date submitted for ethics approval [1] 298027 0
21/04/2017
Approval date [1] 298027 0
24/05/2017
Ethics approval number [1] 298027 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75742 0
Dr Matthew Liptak
Address 75742 0
Flinders Private Hospital, Ground Floor,
1 Flinders Drive,
Bedford Park SA 5042
Country 75742 0
Australia
Phone 75742 0
+618 8267 8237
Fax 75742 0
Email 75742 0
[email protected]
Contact person for public queries
Name 75743 0
Annika Theodoulou
Address 75743 0
The International Musculoskeletal Research Institute Inc.
13 Laffers Road,
Belair, SA 5052,
Country 75743 0
Australia
Phone 75743 0
+618 7231 8452
Fax 75743 0
Email 75743 0
[email protected]
Contact person for scientific queries
Name 75744 0
Annika Theodoulou
Address 75744 0
The International Musculoskeletal Research Institute Inc.
13 Laffers Road,
Belair, SA 5052,
Country 75744 0
Australia
Phone 75744 0
+618 7231 8452
Fax 75744 0
Email 75744 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.