Anterior Cruciate Ligament InjuriesNCT04531826
The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial
A study testing 5-strand hamstring graft preparation in people with Anterior Cruciate Ligament Injuries, run by Hospital Authority, Hong Kong.
Trial summary
Anterior cruciate ligament (ACL) reconstruction is one of most commonly performed orthopaedic surgeries. Several options for graft choice are available and autologous single bundle hamstring graft is most commonly used. Variability exists among patients in terms of hamstring size, and therefore the graft diameter. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- 5-strand hamstring graft preparation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-50
- Symptoms and physical examinations consistent with ACL deficiency and magnetic resonance imaging indicating ACL injury
Who cannot join
- Previous surgeries in the operated knee
- Revision ACL reconstruction
- Contralateral ACL injury
- Concomitant posterior cruciate ligament / collateral ligament surgeries in the operated knee
Trial locations and contacts
No sites are listed yet.
Keith Hay-Man Wan, FRCSEd (Orth) contact
About this study
Anterior cruciate ligament (ACL) reconstruction is one of most commonly performed orthopaedic surgeries. Several options for graft choice are available and autologous single bundle hamstring graft is most commonly used. Variability exists among patients in terms of hamstring size, and therefore the graft diameter. Recently there has been an increasing amount of literature correlating the hamstring graft diameter with the graft failure rate [1-4]. They concluded that graft exceeding 8mm in diameter is associated with a significant lower risk of graft failure. There has been study showing that Asian patients were indeed 'different' from the Caucasians. Ho et al published his findings on Singaporean patients showing that the median graft diameters for female and male patients were 7mm and 8mm respectively [5]. A retrospective review our patients undergoing ACL reconstruction in our department over the past 10 years has shown that the mean graft diameter was 7.8mm (range, 5.5-10mm).
The conventional way of four-strand hamstring autograft is done by doubling both the semitendinosus and gracilis tendons to provide a quadrupled graft. Several techniques have been described to increase the size of the hamstring graft. One of those is the -strand hamstring graft, in which the longer semitendinosus tendon is tripled with the shorter gracilis tendon doubled to produce a 5-strand configuration. We hypothesized that the 5-strand hamstring graft would provide a graft of significantly larger diameter than the conventional quadrupled autograft.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- 5-strand hamstring graft preparation
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-strand hamstring graft preparationOther
Five-strand hamstring graft preparation
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Five-strand hamstring autograft group Receives: Other: 5-strand hamstring graft preparation |
| Group B | Placebo comparator | Quadripled hamstring autograft group Receives: Other: 5-strand hamstring graft preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean graft diameter
Measured: Intra-operative
Secondary outcomes (3)
Adverse event
intra-operative complications, infections, venous thromboembolism
Measured: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
ACL failure
Graft failure / re-rupture, ACL revision, contralateral ACL injury
Measured: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
Clinical measures of knee function and structure
strength testing, hoop test, range of motion, knee osteoarthritis.
Measured: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Keith Hay-Man Wan, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531826
- Sponsor's protocol ID
- HAREC1
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Five-strand Hamstring Autograft to Increase the Graft Size in Anterior Cruciate Ligament Reconstruction - a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04531826
- Acronym / sponsor ID
- HAREC1
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anterior cruciate ligament (ACL) reconstruction is one of most commonly performed orthopaedic surgeries. Several options for graft choice are available and autologous single bundle hamstring graft is most commonly used. Variability exists among patients in terms of hamstring size, and therefore the graft diameter. Recently there has been an increasing amount of literature correlating the hamstring graft diameter with the graft failure rate [1-4]. They concluded that graft exceeding 8mm in diameter is associated with a significant lower risk of graft failure. There has been study showing that Asian patients were indeed 'different' from the Caucasians. Ho et al published his findings on Singaporean patients showing that the median graft diameters for female and male patients were 7mm and 8mm respectively [5]. A retrospective review our patients undergoing ACL reconstruction in our department over the past 10 years has shown that the mean graft diameter was 7.8mm (range, 5.5-10mm).
The conventional way of four-strand hamstring autograft is done by doubling both the semitendinosus and gracilis tendons to provide a quadrupled graft. Several techniques have been described to increase the size of the hamstring graft. One of those is the -strand hamstring graft, in which the longer semitendinosus tendon is tripled with the shorter gracilis tendon doubled to produce a 5-strand configuration. We hypothesized that the 5-strand hamstring graft would provide a graft of significantly larger diameter than the conventional quadrupled autograft.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: 5-strand hamstring graft preparationFive-strand hamstring autograft group |
| Group B | Placebo comparator | Other: 5-strand hamstring graft preparationQuadripled hamstring autograft group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18-50
- Symptoms and physical examinations consistent with ACL deficiency and magnetic resonance imaging indicating ACL injury
Key exclusion criteria (4 listed)
- Previous surgeries in the operated knee
- Revision ACL reconstruction
- Contralateral ACL injury
- Concomitant posterior cruciate ligament / collateral ligament surgeries in the operated knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-strand hamstring graft preparationFive-strand hamstring graft preparation | Other | Group A, Group B |
Primary outcome
Mean graft diameter
Time frame: Intra-operative
3 secondary outcomes
Adverse event
Time frame: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
ACL failure
Time frame: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
Clinical measures of knee function and structure
Time frame: Post-operative 3 months, 6 months, 9 months, 12 months, 18 months and 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Hay-Man Wan, FRCSEd (Orth) contact
Questions about this trial
What is this clinical trial studying?
A study testing 5-strand hamstring graft preparation in people with Anterior Cruciate Ligament Injuries, run by Hospital Authority, Hong Kong.
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 2 inclusion and 4 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Keith Hay-Man Wan, FRCSEd (Orth) (+852 35178089, keithayman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean graft diameter (time frame: Intra-operative). 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 31 Aug 2020.