Anterior Cruciate Ligament InjuriesBEASTNCT04049292
Better and Safer Return to Sport
A study testing Better and safer return to sport (BEAST) in people with Anterior Cruciate Ligament Injuries and Sport Injury, run by Norwegian School of Sport Sciences at 2 sites in Norway.
Trial summary
A prospective cohort design will be used to assess differences in outcomes between pivoting sport athletes with anterior cruciate ligament reconstruction (ACLR) who follow usual care and those who follow a treatment algorithm with a RTS and rehabilitation tool. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Sport Injury
- What is being tested?
- Better and safer return to sport (BEAST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesNorway
- Study dates
- 27 Mar 2019to 31 May 2024
- 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 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- primary anterior cruciate ligament reconstruction 6 months ago (+- 2 weeks)
- age 15-40 years at the time of anterior cruciate ligament injury
- preinjury participation in level I pivoting sport at least 2 times per week
- expressed goal to return to level I sport
Who cannot join
- grade 3 injury to the medial collateral ligament, lateral collateral ligament, or posterior cruciate ligament
- contralateral ACL tear
- inability to understand the native language in the country of recruitment
- other serious injury or illness that impairs function
- has access to specialist sports medicine care (e.g., health support from national team) not accessible to all athletes
- derives primary income from sports participation
- member of sports health team present at the majority of the team's training sessions
Trial locations and contacts
2 sites in 1 country.
Norway2 sites, 2 recruiting
- Recruiting
Norsk Idrettsmedisinsk Institutt
Oslo, 0806
Hege Grindem, PT PhD, hege.grindem@nimi.no
Hege Grindem, PT PhD
- Recruiting
Idrettens helsesenter
Oslo
Håvard Moksnes, PT PhD, havard.moksnes@idrettshelse.no
Håvard Moksnes, PT PhD
About this study
Official title: Better and Safer Return to Sport After Anterior Cruciate Ligament Reconstruction
A prospective cohort design will be used to assess differences in outcomes between pivoting sport athletes with anterior cruciate ligament reconstruction (ACLR) who follow usual care and those who follow a treatment algorithm with a RTS and rehabilitation tool. Athletes aged 15-40 at injury with primary ACLR who express a goal to return to sports with frequent pivoting are eligible. The RTS and rehabilitation tool includes standardized clinical, functional and muscle strength testing 6, 8, 10, and 12 months after surgery. Individual test results guide progression in sports participation and the content of further rehabilitation according to a standardized algorithm.
Read the detailed description
Fewer than half of athletes with ACLR return to competitive sports, and, for those who return, 1 in 5 sustain reinjury. Insufficient functional recovery and poor psychological readiness to RTS are thought to contribute to these low RTS rates and high reinjury rates. Previous research has shown that return to sport (RTS) should be delayed until the athlete passes the criteria of a clinical decision-making tool for RTS. However, to successfully improve RTS and reinjury outcomes, it is imperative that a decision-making tool (1) guides RTS decisions at a specific point in time, and (2) directs the planning and execution of treatments that eventually enable the athlete to safely RTS.
Nonprofessional athletes are often discharged from rehabilitation prior to RTS, and most are treated by rehabilitation clinicians who do not have access to the sophisticated and expensive test equipment used in previous research on functional readiness for RTS. The RTS and rehabilitation tool is therefore designed in collaboration with athletes, coaches and primary care physical therapists as a low-cost intervention that is feasible to implement on a broad scale.
The athletes who follow the RTS and rehabilitation tool will be recruited from Oslo, Norway, while the control group that receives usual care will be recruited from the Swedish Knee Ligament register (SPARX study Dnr 2019-04546).
Predefined adjustment factors for the comparative analyses are: age, sex, specific preinjury sport, family history of ACL injury, time from injury to surgery, meniscal and cartilage injury at ACLR, meniscal repair, and ACL graft type. The analysis of reinjury will be adjusted for sports exposure.
Objectives
- To compare 1 and 2-year sports participation, psychological readiness to RTS, knee function and reinjury outcomes between athletes with ACLR who follow a treatment algorithm with a RTS and rehabilitation tool and those who follow usual care
- To assess adherence and barriers to adherence in athletes with ACLR who follow a treatment algorithm with a RTS and rehabilitation tool
- Conditions
- Anterior Cruciate Ligament Injuries, Sport Injury
- Being tested
- Better and safer return to sport (BEAST), Usual care
- Keywords
- anterior cruciate ligament, return to sport, anterior cruciate ligament reconstruction, rehabilitation
- 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.
Better and safer return to sport (BEAST)Other
The RTS assessment includes a Lachman test, modified stroke test, side hop test, triple hop test, and quadriceps muscle power test. The sport-specific progression plans have 6 participation levels in practice and 6 participation levels in match play. A minimum of 2 weeks and 4 training sessions without pain or effusion must be completed before the athlete progresses to the next level. Criteria for full, unrestricted participation in practice: (1)at least 9 months from ACLR, (2)modified stroke test grade 0, (3)completed previous levels in the sport-specific progression plan, (4)negative Lachman test, (5)side hop test limb symmetry at least 90%, (6)triple hop test limb symmetry at least 90%, (7)quadriceps power symmetry at least 90%. The strength training and knee control exercise protocols each have 3-4 different exercises of 3-4 sets that are performed 3 days per week.
Usual careOther
Usual care is determined by the treating health care professional
| Study group | Role | What they receive |
|---|---|---|
| RTS and rehabilitation tool | Experimental | Six months after ACLR, athletes will commence a standardized RTS assessment. The athlete will follow a standardized, sport-specific progression protocol designed to increase athletic confidence and trust in the knee during sports. Readiness to return to full, unrestricted practice will be determined based on 7 time-based, load-based, clinical and functional criteria. If the athlete fails any of the criteria, he or she will continue to participate in restricted practice. Depending on which of the specific criteria the athlete fails, a targeted treatment plan will be developed. Standardized protocols for effusion management, knee control and strength training will be triggered if the athlete fails the criteria for knee joint effusion, hopping and muscle strength, respectively. The RTS assessment and development of the targeted treatment plan will be repeated every 2 months until the athlete is cleared to RTS, up to a maximum of 12 months after ACLR. Receives: Other: Better and safer return to sport (BEAST) |
| Usual care | Active comparator | Athletes will receive usual care as determined by their treating health care professional Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return to sport
Participation in preinjury sport (yes/no)
Measured: 2 years after ACLR
Reinjury
Injury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)
Measured: 2 years after ACLR
Secondary outcomes (4)
International knee documentation committee subjective knee form
Patient-reported measure of knee symptoms, function and activity level, scored 0-100
Measured: 2 years after ACLR
Anterior cruciate ligament return to sport after injury
Patient-reported measure of emotions, confidence in performance, and risk appraisal in relation to RTS, scored 0-100
Measured: 2 years after ACLR
Adherence/fidelity to the intervention
Project-specific questionnaire
Measured: Monthly self-report 7-14 months after ACLR
Barriers and motivating factors for adherence to the intervention
Self-reported on a project-specific questionnaire
Measured: 14 months after ACLR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start27 Mar 2019
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy, International Olympic Committee, Swedish Research Council for Sport Science, Linkoeping University, Karolinska Institutet
- Responsible party
- Principal investigator, Hege Grindem, Norwegian School of Sport Sciences
- Investigators
- Hege Grindem, PT PhD, Principal investigator, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049292
- Sponsor's protocol ID
- 2018/1886
- Acronym
- BEAST
- Status last verified
- Mar 2023
- First submitted
- 2 Aug 2019
- Last updated
- 23 Mar 2023
- 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 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better and Safer Return to Sport After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04049292
- Acronym / sponsor ID
- BEAST / 2018/1886
- Conditions
- Anterior Cruciate Ligament Injuries, Sport Injury
- Keywords
- anterior cruciate ligament, return to sport, anterior cruciate ligament reconstruction, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy, International Olympic Committee, Swedish Research Council for Sport Science, Linkoeping University, Karolinska Institutet
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 8 Aug 2019 (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.
A prospective cohort design will be used to assess differences in outcomes between pivoting sport athletes with anterior cruciate ligament reconstruction (ACLR) who follow usual care and those who follow a treatment algorithm with a RTS and rehabilitation tool. Athletes aged 15-40 at injury with primary ACLR who express a goal to return to sports with frequent pivoting are eligible. The RTS and rehabilitation tool includes standardized clinical, functional and muscle strength testing 6, 8, 10, and 12 months after surgery. Individual test results guide progression in sports participation and the content of further rehabilitation according to a standardized algorithm.
Detailed description
Fewer than half of athletes with ACLR return to competitive sports, and, for those who return, 1 in 5 sustain reinjury. Insufficient functional recovery and poor psychological readiness to RTS are thought to contribute to these low RTS rates and high reinjury rates. Previous research has shown that return to sport (RTS) should be delayed until the athlete passes the criteria of a clinical decision-making tool for RTS. However, to successfully improve RTS and reinjury outcomes, it is imperative that a decision-making tool (1) guides RTS decisions at a specific point in time, and (2) directs the planning and execution of treatments that eventually enable the athlete to safely RTS.
Nonprofessional athletes are often discharged from rehabilitation prior to RTS, and most are treated by rehabilitation clinicians who do not have access to the sophisticated and expensive test equipment used in previous research on functional readiness for RTS. The RTS and rehabilitation tool is therefore designed in collaboration with athletes, coaches and primary care physical therapists as a low-cost intervention that is feasible to implement on a broad scale.
The athletes who follow the RTS and rehabilitation tool will be recruited from Oslo, Norway, while the control group that receives usual care will be recruited from the Swedish Knee Ligament register (SPARX study Dnr 2019-04546).
Predefined adjustment factors for the comparative analyses are: age, sex, specific preinjury sport, family history of ACL injury, time from injury to surgery, meniscal and cartilage injury at ACLR, meniscal repair, and ACL graft type. The analysis of reinjury will be adjusted for sports exposure.
Objectives
- To compare 1 and 2-year sports participation, psychological readiness to RTS, knee function and reinjury outcomes between athletes with ACLR who follow a treatment algorithm with a RTS and rehabilitation tool and those who follow usual care
- To assess adherence and barriers to adherence in athletes with ACLR who follow a treatment algorithm with a RTS and rehabilitation tool
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTS and rehabilitation tool | Experimental | Other: Better and safer return to sport (BEAST)Six months after ACLR, athletes will commence a standardized RTS assessment. The athlete will follow a standardized, sport-specific progression protocol designed to increase athletic confidence and trust in the knee during sports. Readiness to return to full, unrestricted practice will be determined based on 7 time-based, load-based, clinical and functional criteria. If the athlete fails any of the criteria, he or she will continue to participate in restricted practice. Depending on which of the specific criteria the athlete fails, a targeted treatment plan will be developed. Standardized protocols for effusion management, knee control and strength training will be triggered if the athlete fails the criteria for knee joint effusion, hopping and muscle strength, respectively. The RTS assessment and development of the targeted treatment plan will be repeated every 2 months until the athlete is cleared to RTS, up to a maximum of 12 months after ACLR. |
| Usual care | Active comparator | Other: Usual careAthletes will receive usual care as determined by their treating health care professional |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- primary anterior cruciate ligament reconstruction 6 months ago (+- 2 weeks)
- age 15-40 years at the time of anterior cruciate ligament injury
- preinjury participation in level I pivoting sport at least 2 times per week
- expressed goal to return to level I sport
Key exclusion criteria (7 listed)
- grade 3 injury to the medial collateral ligament, lateral collateral ligament, or posterior cruciate ligament
- contralateral ACL tear
- inability to understand the native language in the country of recruitment
- other serious injury or illness that impairs function
- has access to specialist sports medicine care (e.g., health support from national team) not accessible to all athletes
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 |
|---|---|---|
| Better and safer return to sport (BEAST)The RTS assessment includes a Lachman test, modified stroke test, side hop test, triple hop test, and quadriceps muscle power test. The sport-specific progression plans have 6 participation levels in practice and 6 participation levels in match play. A minimum of 2 weeks and 4 training sessions without pain or effusion must be completed before the athlete progresses to the next level. Criteria for full, unrestricted participation in practice: (1)at least 9 months from ACLR, (2)modified stroke test grade 0, (3)completed previous levels in the sport-specific progression plan, (4)negative Lachman test, (5)side hop test limb symmetry at least 90%, (6)triple hop test limb symmetry at least 90%, (7)quadriceps power symmetry at least 90%. The strength training and knee control exercise protocols each have 3-4 different exercises of 3-4 sets that are performed 3 days per week. | Other | RTS and rehabilitation tool |
| Usual careUsual care is determined by the treating health care professional | Other | Usual care |
Primary outcome
Return to sport
Time frame: 2 years after ACLR
Participation in preinjury sport (yes/no)
Reinjury
Time frame: 2 years after ACLR
Injury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)
4 secondary outcomes
International knee documentation committee subjective knee form
Time frame: 2 years after ACLR
Anterior cruciate ligament return to sport after injury
Time frame: 2 years after ACLR
Adherence/fidelity to the intervention
Time frame: Monthly self-report 7-14 months after ACLR
Barriers and motivating factors for adherence to the intervention
Time frame: 14 months after ACLR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- 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.
Hege Grindem, PT PhD principal investigator
Norwegian School of Sport Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Better and safer return to sport (BEAST) in people with Anterior Cruciate Ligament Injuries and Sport Injury, run by Norwegian School of Sport Sciences at 2 sites in Norway.
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 7 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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 Tone Øritsland (+4723262367, t.h.oritsland@nih.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return to sport (time frame: 2 years after ACLR). The study lists 2 primary outcomes in all. 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 23 Mar 2023; AzTrials last refreshed its copy on 31 Oct 2026.