Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000286943
Ethics application status
Approved
Date submitted
21/02/2020
Date registered
3/03/2020
Date last updated
24/03/2021
Date data sharing statement initially provided
3/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes of Anterior Cruciate Ligament (ACL) Reconstruction with Fresh Frozen Allograft
Scientific title
Clinical and Subjective Outcomes after Anterior Cruciate Ligament (ACL) Reconstruction with Fresh Frozen Allograft
Secondary ID [1] 300621 0
nil
Universal Trial Number (UTN)
U1111-1248-6251
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior Cruciate Ligament Reconstruction 316386 0
Condition category
Condition code
Surgery 314645 314645 0 0
Surgical techniques
Musculoskeletal 314700 314700 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
The anterior cruciate ligament (ACL) is the most commonly injured ligament in the knee. Injury to the ACL often necessitates surgical reconstruction in the subject who wishes to remain active in sidestepping and pivoting activities. ACL surgery is often recommended in subjects to protect their menisci and articular cartilage from damage that can be associated with chronic ACL deficiency.

Autograft tissue has traditionally been the graft of choice among most knee ligament surgeons. The ipsilateral hamstring tendon and bone-patella-tendon-bone is thought by many to be the gold standard autograft tissue of choice. Due to graft site morbidity, the necessity of revision surgeries in some cases and a more difficult rehabilitation, allograft tissue has been investigated by surgeons. As such, the popularity of allograft tissue as a graft choice has increased over the past decade.

The main potential advantages of the use of an allograft in primary ACL reconstruction include no donor site morbidity, no associated weakness of the knee flexor mechanism (as in ipsilateral hamstring grafts), potentially shorter operating time, less post operative pain and availability of larger graft sizes. Allograft potential advantages also extend to revision surgery where larger grafts can be utilised and there is the option to have a bone block attached to the graft.

Literature has shown that allograft is a reasonable alternative to autograft for ACL reconstruction. The majority of the literature available on allografts is from irradiated or chemically treated grafts. To date research that is published on non-irritated fresh frozen allografts including systematic reviews has demonstrated smaller sample sizes or limited measures of patient-orientated outcomes or instrumented laxity. With the increasing availability of human tissue banks and a well established screening, retrieval and testing to minimise the risk of transfer of infection with allografts, there is a need to evaluate a larger sample size of subjects with non-chemically treated grafts.

The aim of this research is to assess the 2 year clinical outcomes of fresh frozen allograft in ACL reconstruction. Assessment will include knee stability, subjective outcomes, return to sport and reinjury at 1 and 2 years after surgery with standardised, reliable and validated assessment tools.
Intervention code [1] 316934 0
Not applicable
Comparator / control treatment
Historic control group who underwent ACL reconstruction with hamstring tendon autograft at the Mater Hospital from 2013-2017 under the care of the investigating surgeons.
Control group
Historical

Outcomes
Primary outcome [1] 322971 0
Clinical outcome of stability of knee as assessed by the International Knee Documentation Committee (IKDC) Evaluation including KT1000 arthrometer measurement.
Timepoint [1] 322971 0
1 year and 2 years post-surgery
Primary outcome [2] 323058 0
Subjective outcome of ACL reconstruction as assessed by the International Knee Documentation Committee (IKDC) Evaluation and Lysholm Knee Score questionnaire.
Timepoint [2] 323058 0
1 year and 2 years post-surgery
Secondary outcome [1] 380399 0
Lower limb posterior tibial slope as assessed by EOS scan.
Timepoint [1] 380399 0
Given posterior tibial slope is part of the bony structure and is unchanged from birth, an EOS scan can be performed at any time point throughout the patients treatment (pre-operative assessment, or any follow-up appointment after surgery - 1 week, 6 weeks, 6 months, 1 year, 2 years).
Secondary outcome [2] 380628 0
Subjective outcomes of ACL reconstruction and return to sport as assessed by the ACL-RSI questionnaire. (composite secondary outcome)
Timepoint [2] 380628 0
1 year and 2 years post-surgery

Eligibility
Key inclusion criteria
1. ACL reconstruction (including revision and bilateral) performed by Professor Leo Pinczewski
2. Allograft utilised as the ACL graft
3. Be willing and capable of providing written informed consent
4. Be willing and capable to attend The Mater Clinic for all post-operative assessments
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who do not wish to participate in a research program
2. Significant chondral damage or degeneration (grade III-IV)
3. Medical conditions that may adversely influence healing progress post-operatively
4. Subjects who are seeking compensation for their injury

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis will be performed using SPSS for Windows software. All data will be assumed to be non-parametric. Statistical significance will be set at p=0.05. Comparison of variables between groups will be analysed with Mann Whitney U tests. Linear variables will be summarised by the mean and 95% confidence interval. Categorical variables will be summarised by frequency.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2020
Actual
15/05/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
200
Accrual to date
100
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305041 0
Self funded/Unfunded
Name [1] 305041 0
Professor Leo Pinczewski
Country [1] 305041 0
Australia
Primary sponsor type
Other Collaborative groups
Name
North Sydney Orthopaedic and Sports Medicine Centre
Address
Suite G.02, 3 GIlies Street
Wollstonecraft
NSW 2065
Country
Australia
Secondary sponsor category [1] 305402 0
None
Name [1] 305402 0
Address [1] 305402 0
Country [1] 305402 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305433 0
St Vincents HREC
Ethics committee address [1] 305433 0
Ethics committee country [1] 305433 0
Australia
Date submitted for ethics approval [1] 305433 0
08/12/2015
Approval date [1] 305433 0
18/12/2015
Ethics approval number [1] 305433 0
15/305

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

Contacts
Principal investigator
Name 100366 0
Prof Leo Pinczewski
Address 100366 0
North Sydney Orthopaedic and Sports Medicine Centre
Suite G.02, 3 Gillies Street
Wollstonecraft
NSW 2065
Country 100366 0
Australia
Phone 100366 0
+61 294375999
Fax 100366 0
+61 294379595
Email 100366 0
[email protected]
Contact person for public queries
Name 100367 0
Claire Monk
Address 100367 0
North Sydney Orthopaedic and Sports Medicine Centre
Suite G.02, 3 Gillies Street
Wollstonecraft
NSW 2065
Country 100367 0
Australia
Phone 100367 0
+61 294090530
Fax 100367 0
+61 294379595
Email 100367 0
[email protected]
Contact person for scientific queries
Name 100368 0
Claire Monk
Address 100368 0
North Sydney Orthopaedic and Sports Medicine Centre
Suite G.02, 3 Gillies Street
Wollstonecraft
NSW 2065
Country 100368 0
Australia
Phone 100368 0
+61 294090530
Fax 100368 0
+61 294379595
Email 100368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.