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Better and Safer Return to Sport

Better and Safer Return to Sport After Anterior Cruciate Ligament Reconstruction

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04049292
Acronym
BEAST
Enrollment
250
Registered
2019-08-08
Start date
2019-03-27
Completion date
2024-05-31
Last updated
2023-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries, Sport Injury

Keywords

anterior cruciate ligament, return to sport, anterior cruciate ligament reconstruction, rehabilitation

Brief 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. 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

Interventions

OTHERBetter 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.

OTHERUsual care

Usual care is determined by the treating health care professional

Sponsors

Norwegian Fund for Postgraduate Training in Physiotherapy
CollaboratorOTHER
International Olympic Committee
CollaboratorUNKNOWN
Swedish Research Council for Sport Science
CollaboratorOTHER
Linkoeping University
CollaboratorOTHER_GOV
Karolinska Institutet
CollaboratorOTHER
Norwegian School of Sport Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Return to sport2 years after ACLRParticipation in preinjury sport (yes/no)
Reinjury2 years after ACLRInjury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)

Secondary

MeasureTime frameDescription
Anterior cruciate ligament return to sport after injury2 years after ACLRPatient-reported measure of emotions, confidence in performance, and risk appraisal in relation to RTS, scored 0-100
Barriers and motivating factors for adherence to the intervention14 months after ACLRSelf-reported on a project-specific questionnaire
Adherence/fidelity to the interventionMonthly self-report 7-14 months after ACLRProject-specific questionnaire
International knee documentation committee subjective knee form2 years after ACLRPatient-reported measure of knee symptoms, function and activity level, scored 0-100

Other

MeasureTime frameDescription
Sports participation2 years after ACLRSelf-reported participation in all sports/physical activity
OSTRC overuse injury questionnaire2 years after ACLROslo Sport Trauma Research Center overuse injury questionnaire

Countries

Norway

Contacts

Primary ContactTone Øritsland
t.h.oritsland@nih.no+4723262367

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026