An interventional study of Spraino in Athletes With Previous Lateral Ankle Sprain(s), sponsored by Spraino. Terminated at 2 sites in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-30.
Sponsored by Spraino · Not applicable, Interventional, and Prevention
This pilot study will establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level, with a one-year follow-up.
All recruited participants will have a history of lateral ankle sprain in the preceding 24 months prior to the initiation of the trial. Half of the included participants will receive Spraino® to prevent lateral ankle sprains (intervention group). The other half will receive no intervention ("do-as-usual" control group). Both groups will be permitted to continue or initiate any usual care of their choice, except Spraino® in the control group. Short Message Services (SMS) will be used for registration of injury and exposure.
The purpose of this exploratory trial (named "The Spraino Pilot Trial") is to establish the preliminary effect and safety of using Spraino® to prevent lateral ankle sprains amongst athletes competing in indoor sports at sub-elite level (handball, basketball, floorball and badminton) when compared to a "do-as-usual" control group.
It is a randomized controlled pilot trial (Pilot-RCT) with a two-group parallel design and blinded outcome assessment. The trial will include prospective injury and exposure registration using a Short Message Services-system (SMS-Track) throughout a 52-week follow-up period (one calendar year).
It is anticipated that 500 participants, which approximates to 250 in each group, will be enrolled in the trial. The enrollment process will cease when at least 250 participants have been allocated to the intervention group. Only athletes participating in indoor sports with a history of a lateral ankle sprain in the preceding 24 months are eligible for inclusion in the trial. The participants will be randomized (1:1 allocation ratio) using numbered lots. The randomization process will ensure stratification for gender, sports discipline and level of play.
A full trial protocol, based on the "SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials" (Chan et al., 2013) and the "PREPARE Trial guide" (Bandholm et al., 2017), will be published and made publicly available. The trial report will adhere to the CONSORT 2010 statement, using the extension for randomized pilot and feasibility trials.
Being an exploratory pilot trial, the study is designed with a flat outcome structure with multiple evenly valued outcome measures. Thus, no primary and secondary outcome measure hierarchy exists.
Inclusion Criteria:
Participants allocated to the intervention group will use Spraino® as a measure to prevent lateral ankle sprains.
Device: Spraino
Participants allocated to the control group will be a "do-as-usual" comparator. This implies, that the participants can treat and prevent lateral ankle sprains in any way they wish, except using Spraino®.
Participants allocated to the intervention group will use Spraino® as a measure to prevent future lateral ankle sprains during all on-court practice sessions and matches. Spraino® is an adhesive polytetrafluoroethylene (PTFE or "Teflon") patch. It is developed with the intent of minimizing lateral shoe- surface friction whenever initial contact is carried out in an inverted position of the ankle joint. Each Spraino® PTFE patch has a minimum durability of 20 hours use and will be provided by the trial sponsor, Spraino® ApS. The participants allocated to the intervention group will receive four pairs of the Spraino® patches via postal service or by hand delivery on a monthly basis, or upon request if material is worn out prematurely during the 52-week trial period.
Lateral ankle sprains
Rate of lateral ankle sprains (continuous) The incidence rate is defined as the number of lateral ankle sprains per 1000 hours of exposure.
Time frame: 52 weeks
First-time non-contact lateral ankle sprains
Rate of first-time non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of first-time non-contact lateral ankle sprains per 1000 hours of exposure.
Time frame: 52 weeks
Time-loss due to first-time non-contact lateral ankle sprains
Time-loss (in number of weeks) due to first-time non-contact lateral ankle sprains per athlete (continuous)
Time frame: 52 weeks
Severe first-time non-contact lateral ankle sprains
Rate of severe first-time non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of severe first-time non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Time frame: 52 weeks
Recurrent non-contact lateral ankle sprains
Rate of recurrent non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of recurrent non-contact lateral ankle sprains per 1000 hours of exposure.
Time frame: 52 weeks
Time-loss due to recurrent non-contact lateral ankle sprains
Time-loss (in number of weeks) due to recurrent non-contact lateral ankle sprains per athlete (continuous)
Time frame: 52 weeks
Severe recurrent non-contact lateral ankle sprains
Rate of severe recurrent non-contact lateral ankle sprains (continuous) The incidence rate is defined as the number of severe recurrent non-contact lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Time frame: 52 weeks
First-time lateral ankle sprains
Rate of first-time lateral ankle sprains (continuous) The incidence rate is defined as the summation of both contact and non-contact first-time lateral ankle sprains per 1000 hours of exposure.
Time frame: 52 weeks
Time-loss due to first-time lateral ankle sprains
Time-loss (in number of weeks) due to first-time lateral ankle sprains per athlete (continuous)
Time frame: 52 weeks
Severe first-time lateral ankle sprains
Rate of severe first-time lateral ankle sprains (continuous) The incidence rate is defined as the number of severe first-time lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Time frame: 52 weeks
Recurrent lateral ankle sprains
Rate of recurrent lateral ankle sprains (continuous) The incidence rate is defined as the summation of both contact and non-contact recurrent lateral ankle sprains per 1000 hours of exposure.
Time frame: 52 weeks
Time-loss due to recurrent lateral ankle sprains
Time-loss (in number of weeks) due to recurrent lateral ankle sprains per athlete (continuous)
Time frame: 52 weeks
Severe recurrent lateral ankle sprains
Rate of severe recurrent lateral ankle sprains (continuous) The incidence rate is defined as the number of severe recurrent lateral ankle sprains (≥ 3 weeks with time-loss) per 1000 hours of exposure.
Time frame: 52 weeks
Adverse effects from using Spraino®
Reports of adverse events in the intervention group (binary) All adverse events will be registered while the participants are enrolled in the trial. Adverse events will be reported as type and number of events. The included participants will be encouraged to report any adverse events related to the use of Spraino® to the trial hotline.
Time frame: 52 weeks
Fear of re-injury
Fear of lateral ankle sprain re-injury (continuous) Change in fear of re-injury from pre- to post-trial intervention period. Fear of re-injury is scored on a numeric rating scale from 0 - 100 (0 = Extremely fear full, 100 = No fear at all)
Time frame: 52 weeks
Ankle pain
Ankle pain (continuous) Change in ankle pain from pre- to post-trial intervention period. Ankle pain is scored on a numeric rating scale from 0 - 10 (0 = No pain at all, 10 = Extremely painful)
Time frame: 52 weeks
Plan to share: Undecided
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