Anterior Cruciate Ligament RuptureHAMSTRINGNCT05464485
Hamstring Muscle Strength After ACL Hamstring Reconstruction
An observational study of Anterior Cruciate Ligament Rupture, run by Isala.
Trial summary
Anterior Cruciate Ligament (ACL) reconstructions using hamstring grafts can be performed using one or two hamstring grafts, the semitendinosus (ST) tendon only, or both the semitendinosus and gracilis (ST/G) tendon. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- ACL hamstring reconstructions using semitendinosus (ST) tendon only and ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendon
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Jul 2018
- Phase
- Observational
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients will be recruited from the Orthopaedic outpatient clinic of the Isala in Zwolle if the patient has an ACL rupture and if there is an indication for surgical reconstruction with the AMP or TLS ACL reconstruction technique or at the (standard) 6 weeks follow-up appointment after AMP or TLS ACL reconstruction surgery
Who may be able to join
- Patient older than 18 years and younger than 60 years old.
- Mentally competent to understand the informed consent.
- Patient underwent AMP or TLS ACL reconstruction surgery or will undergo AMP or TLS ACL reconstruction surgery
Who cannot join
- ACL reconstruction surgery older than 12 weeks.
- Meniscus rupture larger than 25%
- Indication for meniscal repair.
- Injury of the collateral ligaments or posterior cruciate ligament
- History of ACL or meniscal rupture
- Neurological or systemic disorder that inhibit adequate rehabilitation
About this study
Official title: Anterior Cruciate Ligament Hamstring Study: Hamstring Muscle Strength After Anteromedial Portal ACL Reconstruction Versus Tape Locking Screw ACL Reconstruction
Anterior Cruciate Ligament (ACL) reconstructions using hamstring grafts can be performed using one or two hamstring grafts, the semitendinosus (ST) tendon only, or both the semitendinosus and gracilis (ST/G) tendon. As most patients strive to return to sport nine months after reconstruction the purpose of this study was to compare the recovery of hamstring muscle strength during these first nine months after reconstruction using the ST or ST/G tendons.
Read the detailed description
Anterior cruciate ligament (ACL) reconstruction techniques are developing continuously. Studies have shown that anatomical positioning of the femur tunnel is an important predictor for the clinical outcome. This has led to the development of new reconstruction techniques with a more anatomical placement of the femur tunnel: the anteromedial portal (AMP) ACL reconstruction technique and, more recently, the tape locking screw (TLS) ACL reconstruction technique. Multiple retrospective studies have shown that patients have a better short term clinical outcome when the anteromedial portal (AMP) or the tape locking crew (TLS) reconstruction technique is used. At this moment, the most widely used technique is the AMP (performed in approximately 80% of the ACL reconstructions). The TLS technique is widely used in France and the available literature shows good short-term results.
A difference between the AMP and the TLS technique is that the AMP technique uses a double-bundle hamstring graft where the TLS technique uses a single-bundle hamstring graft. The idea is that using a single-bundle hamstring graft causes less hamstring muscle strength deficit. The available literature shows different outcomes of hamstring muscle strength deficit, although, there are no studies found in which the difference in hamstring muscle strength deficit between both techniques directly has been investigated.
Objective: The main objective of this study is to compare the hamstring muscle strength deficit after AMP and TLS reconstruction techniques.
The primary aim of this study is to investigate if there is a difference in hamstring muscle strength deficit at 60°/s flexion in patients with an ACL rupture (18-60 years) who received a tape locking screw ACL reconstruction versus patients who received an anteromedial portal ACL reconstruction 12 weeks after surgery.
The secondary aim of this study is to investigate if there is a difference in muscle strength deficit at 180°/s and 240°/s flexion and extension 12 weeks after surgery and 60°/s, 180°/s and 240°/s flexion and extension 20 weeks after surgery in patients who received a tape locking screw ACL reconstruction versus patients who received an anteromedial portal ACL reconstruction.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- ACL hamstring reconstructions using semitendinosus (ST) tendon only, ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendon
- 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.
ACL hamstring reconstructions using semitendinosus (ST) tendon onlyProcedure or surgery
ACL reconstruction with a ST tendon graft received a reconstruction according to the Tape Locking Screw technique (FH Industrie, Quimper, France) with a dedicated interference screw
ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendonProcedure or surgery
ACL reconstruction with a ST/G tendon graft received a reconstruction with the anteromedial portal technique with endobutton fixation (Smith \& Nephew, London, UK).
| Study group | Role | What they receive |
|---|---|---|
| ACL hamstring reconstructions using semitendinosus (ST) tendon only | Not described Receives: Procedure: ACL hamstring reconstructions using semitendinosus (ST) tendon only | |
| ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendon | Not described Receives: Procedure: ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic muscle strength deficit
Comparing isokinetic muscle strength deficit (measured at 60°/s, 180°/s and 240°/s flexion with a the Biodex dynamometer) between both groups
Measured: 38 weeks post-surgery
Secondary outcomes (1)
Change in isokinetic muscle strength deficit
Comparing the change in isokinetic muscle strength deficit (measured at 60°/s, 180°/s and 240°/s flexion with a the Biodex dynamometer) at 12, 20 and 38 weeks post-surgery
Measured: 12, 20 and 38 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Jan 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart Robben, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464485
- Sponsor's protocol ID
- 60029.075.16
- Acronym
- HAMSTRING
- Status last verified
- Jul 2022
- First submitted
- 10 Jul 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analyzed during the current study are not publicly available due institutional privacy guideline but are available from the corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Cruciate Ligament Hamstring Study: Hamstring Muscle Strength After Anteromedial Portal ACL Reconstruction Versus Tape Locking Screw ACL Reconstruction
- ClinicalTrials.gov ID
- NCT05464485
- Acronym / sponsor ID
- HAMSTRING / 60029.075.16
- Conditions
- Anterior Cruciate Ligament Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 19 Jul 2022 (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) reconstructions using hamstring grafts can be performed using one or two hamstring grafts, the semitendinosus (ST) tendon only, or both the semitendinosus and gracilis (ST/G) tendon. As most patients strive to return to sport nine months after reconstruction the purpose of this study was to compare the recovery of hamstring muscle strength during these first nine months after reconstruction using the ST or ST/G tendons.
Detailed description
Anterior cruciate ligament (ACL) reconstruction techniques are developing continuously. Studies have shown that anatomical positioning of the femur tunnel is an important predictor for the clinical outcome. This has led to the development of new reconstruction techniques with a more anatomical placement of the femur tunnel: the anteromedial portal (AMP) ACL reconstruction technique and, more recently, the tape locking screw (TLS) ACL reconstruction technique. Multiple retrospective studies have shown that patients have a better short term clinical outcome when the anteromedial portal (AMP) or the tape locking crew (TLS) reconstruction technique is used. At this moment, the most widely used technique is the AMP (performed in approximately 80% of the ACL reconstructions). The TLS technique is widely used in France and the available literature shows good short-term results.
A difference between the AMP and the TLS technique is that the AMP technique uses a double-bundle hamstring graft where the TLS technique uses a single-bundle hamstring graft. The idea is that using a single-bundle hamstring graft causes less hamstring muscle strength deficit. The available literature shows different outcomes of hamstring muscle strength deficit, although, there are no studies found in which the difference in hamstring muscle strength deficit between both techniques directly has been investigated.
Objective: The main objective of this study is to compare the hamstring muscle strength deficit after AMP and TLS reconstruction techniques.
The primary aim of this study is to investigate if there is a difference in hamstring muscle strength deficit at 60°/s flexion in patients with an ACL rupture (18-60 years) who received a tape locking screw ACL reconstruction versus patients who received an anteromedial portal ACL reconstruction 12 weeks after surgery.
The secondary aim of this study is to investigate if there is a difference in muscle strength deficit at 180°/s and 240°/s flexion and extension 12 weeks after surgery and 60°/s, 180°/s and 240°/s flexion and extension 20 weeks after surgery in patients who received a tape locking screw ACL reconstruction versus patients who received an anteromedial portal ACL reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACL hamstring reconstructions using semitendinosus (ST) tendon only | – | Procedure: ACL hamstring reconstructions using semitendinosus (ST) tendon only |
| ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendon | – | Procedure: ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendon |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients will be recruited from the Orthopaedic outpatient clinic of the Isala in Zwolle if the patient has an ACL rupture and if there is an indication for surgical reconstruction with the AMP or TLS ACL reconstruction technique or at the (standard) 6 weeks follow-up appointment after AMP or TLS ACL reconstruction surgery
Key inclusion criteria (3 listed)
- Patient older than 18 years and younger than 60 years old.
- Mentally competent to understand the informed consent.
- Patient underwent AMP or TLS ACL reconstruction surgery or will undergo AMP or TLS ACL reconstruction surgery
Key exclusion criteria (6 listed)
- ACL reconstruction surgery older than 12 weeks.
- Meniscus rupture larger than 25%
- Indication for meniscal repair.
- Injury of the collateral ligaments or posterior cruciate ligament
- History of ACL or meniscal rupture
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 |
|---|---|---|
| ACL hamstring reconstructions using semitendinosus (ST) tendon onlyACL reconstruction with a ST tendon graft received a reconstruction according to the Tape Locking Screw technique (FH Industrie, Quimper, France) with a dedicated interference screw | Procedure or surgery | ACL hamstring reconstructions using semitendinosus (ST) tendon only |
| ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendonACL reconstruction with a ST/G tendon graft received a reconstruction with the anteromedial portal technique with endobutton fixation (Smith \& Nephew, London, UK). | Procedure or surgery | ACL hamstring reconstructions using semitendinosus and gracilis (ST/G) tendon |
Primary outcome
Isokinetic muscle strength deficit
Time frame: 38 weeks post-surgery
Comparing isokinetic muscle strength deficit (measured at 60°/s, 180°/s and 240°/s flexion with a the Biodex dynamometer) between both groups
1 secondary outcome
Change in isokinetic muscle strength deficit
Time frame: 12, 20 and 38 weeks post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No. The datasets generated and/or analyzed during the current study are not publicly available due institutional privacy guideline but are available from the corresponding author on reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture, run by Isala.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 19 Jul 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isokinetic muscle strength deficit (time frame: 38 weeks post-surgery). 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 19 Jul 2022.