Physical ActivityNCT03171532
Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament Reconstruction
A study testing Strands of Hamstring Autograft in ACL reconstruction in people with Physical Activity, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
This study aims to study differences in clinical and functional outcomes at 2 years based on hamstring graft size after single bundle anatomic ACL reconstruction using either 4-strand or 5-strand hamstring grafts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Strands of Hamstring Autograft in ACL reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Dec 2015to 31 Dec 2018
- 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
- Age above 18 years
- Clinical and MRI confirmed complete ACL tear
- Ipsilateral hamstring autograft
- Concomitant meniscus injury requiring either meniscus repair or partial menisectomy
- Concomitant chondral injury Grade 0,1,2 (International Cartilage Repair Society)
- Regular scheduled follow up with adherence to prescribed rehab protocol
Who cannot join
- Non consent
- Paediatric patient; age less than 18 years
- Partial or incomplete ACL tear
- Revision ACL surgery
- Hamstring allograft
- Multi-ligament injury of the knee (ACL and/or Posterior Cruciate Ligament, Medial Collateral Ligament, Lateral Collateral Ligament, Postero Lateral Corner)
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- Past history of knee surgery
- Contra-lateral ACL injury or other ligament injury
- Chondral injury Grade 3,4 (International Cartilage Repair Society)
- Intra-articular fracture (past or current)
- Radiologically evident osteoarthritis changes
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Health System
Singapore, 119074
Lingaraj Krishna, FRCS (Orth), +6567795555, lingaraj_krishna@nuhs.edu.sg
Amritpal Singh, MBBS, +6567795555, amritpal_singh@nuhs.edu.sg
About this study
Official title: Comparison of Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament (ACL) Reconstruction: A Prospective Randomized Controlled Trial
This study aims to study differences in clinical and functional outcomes at 2 years based on hamstring graft size after single bundle anatomic ACL reconstruction using either 4-strand or 5-strand hamstring grafts. We also propose to study the characteristics of hamstring graft in our subset of patients in Asian population context.
Read the detailed description
This will be a prospective, randomized interventional study conducted at the National University Hospital under University Orthopaedics and Hand surgery Cluster during the period of December 2015 to December 2018. Study participants: The study will include 80 patients with complete Anterior Cruciate Ligament (ACL) tear undergoing primary arthroscopic reconstruction with ipsilateral hamstring autograft after written informed consent to participate in the study.
The subjects will be divided into two groups A) 4-strand hamstring or B) 5-strand hamstring group by block randomization using an online randomization generator (http://www.graphpad.com/quickcalcs). All the subjects will undergo the procedure by otherwise identical technique performed by single surgeon. At 1 and 2 years functional and subjective outcomes will be assessed.
- Conditions
- Physical Activity
- Being tested
- Strands of Hamstring Autograft in ACL reconstruction
- Keywords
- ACL
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strands of Hamstring Autograft in ACL reconstructionProcedure or surgery
The femoral and tibial ends will be tubularised and the final graft diameter will be recorded after passing through sizing cylinders graduated in 0.5mm increments. The femoral and tibial tunnels will be drilled as per standard technique for single bundle ACL reconstruction via trans-portal or trans-tibial route and both ends fixed by interference screw with additional post on the tibial end.
| Study group | Role | What they receive |
|---|---|---|
| 4 strand hamstring ACL reconstruction | Active comparator | The hamstring tendons will be harvested by standard technique and the lengths of the Semitendinosus and Gracilis tendons will be measured after clearing all adherent muscle tissue. The ends will be prepared and folded in middle to prepare4-strand graft. Receives: Procedure: Strands of Hamstring Autograft in ACL reconstruction |
| 5 strand hamstring ACL reconstruction | Active comparator | The hamstring tendons will be harvested by standard technique and the lengths of the Semitendinosus (ST) and Gracilis (GR) tendons will be measured after clearing all adherent muscle tissue. For 5-strand graft, minimum length of ST and GR in consideration would be 24 cm and 16 cm respectively. For 5-strand group the ST tendon will be be folded twice and sutured on itself to make a three strand graft and then GR tendon will be folded once along with it to make a final 5-strand graft. Receives: Procedure: Strands of Hamstring Autograft in ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline
Patient reported outcome
Measured: Baseline, 1 year and 2 years post op
Secondary outcomes (6)
Tegner-Lysholm Score change from baseline
Patient reported outcome
Measured: Baseline, 1 year and 2 years post op
International Knee Documentation Committee (IKDC) Grade change from baseline
Patient reported outcome
Measured: Baseline, 1 year and 2 years post op
KOOS Pain change from baseline
Patient reported outcome
Measured: Baseline, 1 year and 2 years post op
KOOS Symptoms change from baseline
Patient reported outcome
Measured: Baseline, 1 year and 2 years post op
KOOS Function in daily living (KOOS ADL) change from baseline
Patient reported outcome
Measured: Baseline, 1 year and 2 years post op
KOOS Knee-related Quality of Life (KOOS QOL) change from baseline
Patient reported outcome
Measured: Baseline, 1 year and 2 years post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Dec 2015
- Primary completion1 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lingaraj Krishna, FRCS (Orth), Principal investigator, National University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171532
- Sponsor's protocol ID
- 2015/00652
- Other IDs
- 2015
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical and Functional Outcomes at 2 Years of 4-strand Versus 5-strand Hamstring Autograft in Anterior Cruciate Ligament (ACL) Reconstruction: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03171532
- Acronym / sponsor ID
- 2015/00652
- Conditions
- Physical Activity
- Keywords
- ACL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 31 May 2017 (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.
This study aims to study differences in clinical and functional outcomes at 2 years based on hamstring graft size after single bundle anatomic ACL reconstruction using either 4-strand or 5-strand hamstring grafts. We also propose to study the characteristics of hamstring graft in our subset of patients in Asian population context.
Detailed description
This will be a prospective, randomized interventional study conducted at the National University Hospital under University Orthopaedics and Hand surgery Cluster during the period of December 2015 to December 2018. Study participants: The study will include 80 patients with complete Anterior Cruciate Ligament (ACL) tear undergoing primary arthroscopic reconstruction with ipsilateral hamstring autograft after written informed consent to participate in the study.
The subjects will be divided into two groups A) 4-strand hamstring or B) 5-strand hamstring group by block randomization using an online randomization generator (http://www.graphpad.com/quickcalcs). All the subjects will undergo the procedure by otherwise identical technique performed by single surgeon. At 1 and 2 years functional and subjective outcomes will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4 strand hamstring ACL reconstruction | Active comparator | Procedure: Strands of Hamstring Autograft in ACL reconstructionThe hamstring tendons will be harvested by standard technique and the lengths of the Semitendinosus and Gracilis tendons will be measured after clearing all adherent muscle tissue. The ends will be prepared and folded in middle to prepare4-strand graft. |
| 5 strand hamstring ACL reconstruction | Active comparator | Procedure: Strands of Hamstring Autograft in ACL reconstructionThe hamstring tendons will be harvested by standard technique and the lengths of the Semitendinosus (ST) and Gracilis (GR) tendons will be measured after clearing all adherent muscle tissue. For 5-strand graft, minimum length of ST and GR in consideration would be 24 cm and 16 cm respectively. For 5-strand group the ST tendon will be be folded twice and sutured on itself to make a three strand graft and then GR tendon will be folded once along with it to make a final 5-strand graft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 18 years
- Clinical and MRI confirmed complete ACL tear
- Ipsilateral hamstring autograft
- Concomitant meniscus injury requiring either meniscus repair or partial menisectomy
- Concomitant chondral injury Grade 0,1,2 (International Cartilage Repair Society)
Key exclusion criteria (11 listed)
- Non consent
- Paediatric patient; age less than 18 years
- Partial or incomplete ACL tear
- Revision ACL surgery
- Hamstring allograft
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 |
|---|---|---|
| Strands of Hamstring Autograft in ACL reconstructionThe femoral and tibial ends will be tubularised and the final graft diameter will be recorded after passing through sizing cylinders graduated in 0.5mm increments. The femoral and tibial tunnels will be drilled as per standard technique for single bundle ACL reconstruction via trans-portal or trans-tibial route and both ends fixed by interference screw with additional post on the tibial end. | Procedure or surgery | 4 strand hamstring ACL reconstruction, 5 strand hamstring ACL reconstruction |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline
Time frame: Baseline, 1 year and 2 years post op
Patient reported outcome
6 secondary outcomes
Tegner-Lysholm Score change from baseline
Time frame: Baseline, 1 year and 2 years post op
International Knee Documentation Committee (IKDC) Grade change from baseline
Time frame: Baseline, 1 year and 2 years post op
KOOS Pain change from baseline
Time frame: Baseline, 1 year and 2 years post op
KOOS Symptoms change from baseline
Time frame: Baseline, 1 year and 2 years post op
KOOS Function in daily living (KOOS ADL) change from baseline
Time frame: Baseline, 1 year and 2 years post op
KOOS Knee-related Quality of Life (KOOS QOL) change from baseline
Time frame: Baseline, 1 year and 2 years post op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: No
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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.
Lingaraj Krishna, FRCS (Orth) principal investigator
National University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strands of Hamstring Autograft in ACL reconstruction in people with Physical Activity, run by National University Hospital, Singapore at 1 site in Singapore.
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 6 inclusion and 11 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 May 2017. 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 Singapore. 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?
Contact Lingaraj Krishna, FRCS (Orth) (+6567795555, lingaraj_krishna@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (KOOS) Sport/Rec Score (Function in Sport and Recreation) change from baseline (time frame: Baseline, 1 year and 2 years post op). 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 May 2017.