Hamstring ContracturesPhase 3SCALANCT05008731
Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
A Phase 3 study testing Botulinum toxin in people with Hamstring Contractures, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Monocentric, prospective, randomised, double-blind study of two parallel groups of 66 patients with post-reconstruction ACL hamstring contracture treated with an ultrasound-guided injection at two points on the body of the hamstring Group 1: botulinum toxin: 100 units (0.5ml) in 1 injection Group 2: placebo: 0.5 ml in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hamstring Contractures
- What is being tested?
- Botulinum toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2024to 20 Feb 2026
- Phase
- Phase 3
- 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
- Patient over 18 years of age
- Patient who has read and signed the consent form for participation in the study
- Patient operated on for primary ACL ligamentoplasty with or without meniscal repair
- Patient with reducible flatus >10° at 1 month post ligamentoplasty
Who cannot join
- Revision ligamentoplasty
- Multi-ligament knee
- Patient under court protection, guardianship or trusteeship
- Patient not affiliated to the French social security system
- Patient participating in another therapeutic protocol
- Pregnant woman or woman of childbearing age without effective contraception
Show all 11Show fewer
- Patient unable to understand the informed information and/or to give written informed consent: dementia, psychosis, disturbed consciousness, non-French speaking patient
- Patient with known hypersensitivity to botulinum toxin
- Patient with peripheral neuromuscular dysfunction or pronounced atrophy of the semitendinosus muscle
- Patient treated with anticoagulants, chloroquine (or hydroxychloroquine)
- Patient treated in the previous seven days with antibiotics or muscle relaxants (such as tubocurarine)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
Monocentric, prospective, randomised, double-blind study of two parallel groups of 66 patients with post-reconstruction ACL hamstring contracture treated with an ultrasound-guided injection at two points on the body of the hamstring
- Group 1: botulinum toxin: 100 units (0.5ml) in 1 injection
- Group 2: placebo: 0.5 ml in 1 injection
Read the detailed description
The study includes three assessments: one month after ligamentoplasty (inclusion visit) and then at M2 and M5. The therapeutic benefit of the study treatments is based on the evolution of the extension defect at M2.
- Conditions
- Hamstring Contractures
- Being tested
- Botulinum toxin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxinDrug
100 units (0.5ml) in 1 injection
PlaceboOther
Placebo 0.5 ml in 1 injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | botulinum toxin: 100 units (0.5ml) in 1 injection Receives: Drug: Botulinum toxin |
| Group 2 | Placebo comparator | Placebo: 0.5 ml in 1 injection Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of therapeutic success, defined by the absence of extension defect at M3 post ligamentoplasty, will be compared between the groups by a Chi-2 test.
Therapeutic success is defined by the absence of extension defect (0 degree of flessum) at 2 months post botulinum toxin injection
Measured: Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start18 Jul 2024
- Primary completion20 Feb 2026
- Study completion20 Feb 2026
Why it stopped: The site had difficulties to recruit. Some associated investigators can not be involved in the study anymore and others centers contacted don't have enough ressources to conduct the study. Premature end of inclusions on 07/10/2025 \& LPLV on11/27/2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring ContracturesStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, prospective, randomised, double-blind study of two parallel groups of 66 patients with post-reconstruction ACL hamstring contracture treated with an ultrasound-guided injection at two points on the body of the hamstring * Group 1: botulinum toxin: 100 units (0.5ml) in 1 injection * Group 2: placebo: 0.5 ml in 1 injection
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Hardy, MD, Principal investigator, Clinique du sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008731
- Sponsor's protocol ID
- 2020-005742-42
- Acronym
- SCALA
- Status last verified
- Jun 2026
- First submitted
- 16 Aug 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Botulinum Toxin on Hamstring Contracture and the Occurrence of Cyclops Syndrome After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05008731
- Acronym / sponsor ID
- SCALA / 2020-005742-42
- Conditions
- Hamstring Contractures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The site had difficulties to recruit. Some associated investigators can not be involved in the study anymore and others centers contacted don't have enough ressources to conduct the study. Premature end of inclusions on 07/10/2025 \& LPLV on11/27/2025
- Enrolment
- 13 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 17 Aug 2021 (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.
Monocentric, prospective, randomised, double-blind study of two parallel groups of 66 patients with post-reconstruction ACL hamstring contracture treated with an ultrasound-guided injection at two points on the body of the hamstring
- Group 1: botulinum toxin: 100 units (0.5ml) in 1 injection
- Group 2: placebo: 0.5 ml in 1 injection
Detailed description
The study includes three assessments: one month after ligamentoplasty (inclusion visit) and then at M2 and M5. The therapeutic benefit of the study treatments is based on the evolution of the extension defect at M2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Monocentric, prospective, randomised, double-blind study of two parallel groups of 66 patients with post-reconstruction ACL hamstring contracture treated with an ultrasound-guided injection at two points on the body of the hamstring * Group 1: botulinum toxin: 100 units (0.5ml) in 1 injection * Group 2: placebo: 0.5 ml in 1 injection
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Botulinum toxinbotulinum toxin: 100 units (0.5ml) in 1 injection |
| Group 2 | Placebo comparator | Other: PlaceboPlacebo: 0.5 ml in 1 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient over 18 years of age
- Patient who has read and signed the consent form for participation in the study
- Patient operated on for primary ACL ligamentoplasty with or without meniscal repair
- Patient with reducible flatus >10° at 1 month post ligamentoplasty
Key exclusion criteria (11 listed)
- Revision ligamentoplasty
- Multi-ligament knee
- Patient under court protection, guardianship or trusteeship
- Patient not affiliated to the French social security system
- Patient participating in another therapeutic protocol
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 |
|---|---|---|
| Botulinum toxin100 units (0.5ml) in 1 injection | Drug | Group 1 |
| PlaceboPlacebo 0.5 ml in 1 injection | Other | Group 2 |
Primary outcome
The percentage of therapeutic success, defined by the absence of extension defect at M3 post ligamentoplasty, will be compared between the groups by a Chi-2 test.
Time frame: Month 2
Therapeutic success is defined by the absence of extension defect (0 degree of flessum) at 2 months post botulinum toxin injection
Results and safety
The study was stopped early (reason given: The site had difficulties to recruit. Some associated investigators can not be involved in the study anymore and others centers contacted don't have enough ressources to conduct the study. Premature end of inclusions on 07/10/2025 \& LPLV on11/27/2025). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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.
Alexandre Hardy, MD principal investigator
Clinique du sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin in people with Hamstring Contractures, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 4 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: stopped early, as of the sponsor's last update on 5 Jun 2026. 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 France. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The site had difficulties to recruit. Some associated investigators can not be involved in the study anymore and others centers contacted don't have enough ressources to conduct the study. Premature end of inclusions on 07/10/2025 \& LPLV on11/27/2025). Results are not available in the source record.
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?
The percentage of therapeutic success, defined by the absence of extension defect at M3 post ligamentoplasty, will be compared between the groups by a Chi-2 test. (time frame: Month 2). 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 5 Jun 2026.