Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001444572
Ethics application status
Approved
Date submitted
4/11/2024
Date registered
11/12/2024
Date last updated
5/09/2025
Date data sharing statement initially provided
11/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Prevalence of Quadriceps and Hamstring Strength Deficits among Anterior Cruciate Ligament Reconstruction Patients
Scientific title
Prevalence of Quadriceps and Hamstring Strength Deficits among Anterior Cruciate Ligament Reconstruction Patients: A Retrospective Longitudinal Study
Secondary ID [1] 313285 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior cruciate ligament 335621 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332180 332180 0 0
Physiotherapy
Musculoskeletal 332536 332536 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
This study will employ a retrospective, longitudinal design using secondary data. The data will be collected from the medical records of patients who underwent anterior cruciate ligament reconstruction (ACLR) at the Hospital Canselor Tuanku Muhriz (HCTM) over a four-year period from January 2020 to December 2023. The study population will consist of all adult patients over 18 years old who underwent ACLR at the hospital and have documented preoperative and postoperative assessments of knee muscle strength and physical function at the Orthopaedic ward/clinic and Physiotherapy Unit of HCTM.

The primary outcomes of this study are 1) the percentage of quadriceps and hamstring strength between operated and non-operated knees and 2) the functional performance (single-leg hop test).

The secondary and exploratory outcomes measure patient-reported outcomes on symptoms, function, and sports activity based on the International Knee Documentation Committee (IKDC) questionnaire score and the level of patient adherence to rehabilitation sessions.

All the outcome measures will be obtained from the patient's medical record, as evaluated by the physiotherapist and physician in the HCTM between preoperative, 3-month, and 6-month postoperative ACLR.
Intervention code [1] 329861 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339776 0
Quadriceps strength
Timepoint [1] 339776 0
preoperative, 3-month, and 6-month post-ACLR.
Primary outcome [2] 340053 0
Hamstring strength
Timepoint [2] 340053 0
preoperative, 3-month, and 6-month post-ACLR.
Primary outcome [3] 340056 0
Physical function
Timepoint [3] 340056 0
Preoperative and 6-month post-ACLR.
Secondary outcome [1] 441269 0
The patient-reported outcomes on symptoms, function, and sports activity will be assessed collectively as a composite outcome.
Timepoint [1] 441269 0
Preoperative, 3-month, and 6-month post-ACLR.
Secondary outcome [2] 442501 0
Patient adherence to rehabilitation programs
Timepoint [2] 442501 0
Preoperative, 3-month, and 6-month post-ACLR.

Eligibility
Key inclusion criteria
1) Patients who have completed at least 6 months of follow-up post-ACLR surgery.
2) Patients with complete and accessible medical records, including preoperative, intraoperative, and postoperative data.
3) Patients who have undergone standardized assessments of knee muscle strength, physical function, or related evaluations at specified intervals post-surgery (e.g., pre-operatively, 3 and 6 months).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients with missing or incomplete data related to key variables of interest in the study.
2) Female patients who were pregnant at the time of follow-up assessments, as pregnancy may affect physical function and muscle strength.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive statistics will be employed to concisely summarise the characteristics of the participants and the prevalence of impairments in knee muscle and physical function. The analysis will use Chi-square tests to estimate the frequency of the study population's demographic characteristics and categorical variables (type of graft, concomitant bone/chondral lesion and level of adherence), as well as linear regression analysis to identify influence factors and predictors of ACLR outcome. Furthermore, the Pearson correlation test will be employed for continuous variables and normally distributed data, or the Spearman correlation for ordinal or non-normally distributed data. The Bonferroni post-hoc test will be performed to identify differences in the relevant analysis. The significance level is set at P <0.05. Additionally, the odds ratio (OR), 95% confidence interval (CI), or Z-score will be included.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/12/2024
Actual
19/12/2024
Date of last participant enrolment
Anticipated
31/05/2025
Actual
9/06/2025
Date of last data collection
Anticipated
30/06/2025
Actual
1/07/2025
Sample size
Target
108
Accrual to date
Final
104
Recruitment outside Australia
Country [1] 26667 0
Malaysia
State/province [1] 26667 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 317736 0
Hospital
Name [1] 317736 0
Hospital Canselor Tuanku Muhriz UKM
Country [1] 317736 0
Malaysia
Primary sponsor type
Hospital
Name
Hospital Canselor Tuanku Muhriz UKM
Address
Country
Malaysia
Secondary sponsor category [1] 320049 0
None
Name [1] 320049 0
Address [1] 320049 0
Country [1] 320049 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316424 0
UKM Research Ethic Committee (RECUKM)
Ethics committee address [1] 316424 0
Ethics committee country [1] 316424 0
Malaysia
Date submitted for ethics approval [1] 316424 0
24/09/2024
Approval date [1] 316424 0
18/11/2024
Ethics approval number [1] 316424 0
JEP-2024-849

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

Contacts
Principal investigator
Name 137846 0
A/Prof Badrul Akmal Hisham Bin Md. Yusoff
Address 137846 0
Hospital Canselor Tuanku Muhriz, UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 137846 0
Malaysia
Phone 137846 0
+60125196119
Fax 137846 0
Email 137846 0
[email protected]
Contact person for public queries
Name 137847 0
Efri Noor Bin Muhamad Hendri
Address 137847 0
Hospital Canselor Tuanku Muhriz, UKM, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras, Wilayah Persekutuan Kuala Lumpur
Country 137847 0
Malaysia
Phone 137847 0
+60132117407
Fax 137847 0
Email 137847 0
[email protected]
Contact person for scientific queries
Name 137848 0
Mohamad Shariff Bin A Hamid
Address 137848 0
Jabatan Perubatan Kesukanan, Tingkat 5, Menara Selatan, Pusat Perubatan Universiti Malaya, Lembah Pantai, 59100 Kuala Lumpur
Country 137848 0
Malaysia
Phone 137848 0
+60122065452
Fax 137848 0
Email 137848 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers

• Journal editors, peer reviewers (for manuscript evaluation), and qualified researchers with a sound proposal and ethics approval

Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.