Better and Safer Return to Sport

Anterior Cruciate Ligament Injuries Clinical Trial

— BEAST  

Official title:

Better and Safer Return to Sport After Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04049292
• Other study ID #: 2018/1886
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: March 2023
• Source: Norwegian School of Sport Sciences
• Contact: Tone Øritsland
• Phone: +4723262367
• Email: t.h.oritsland[@]nih.no
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Athletic Injuries
• Sport Injury
• Wounds and Injuries

Intervention

Other:
• 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.
• Usual care
Usual care is determined by the treating health care professional

Locations

Country	Name	City	State
Norway	Idrettens helsesenter	Oslo
Norway	Norsk Idrettsmedisinsk Institutt	Oslo

Sponsors (6)

Lead Sponsor	Collaborator
Norwegian School of Sport Sciences	International Olympic Committee, Karolinska Institutet, Linkoeping University, Norwegian Fund for Postgraduate Training in Physiotherapy, Swedish Research Council for Sport Science

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sports participation	Self-reported participation in all sports/physical activity	2 years after ACLR
Other	OSTRC overuse injury questionnaire	Oslo Sport Trauma Research Center overuse injury questionnaire	2 years after ACLR
Primary	Return to sport	Participation in preinjury sport (yes/no)	2 years after ACLR
Primary	Reinjury	Injury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)	2 years after ACLR
Secondary	International knee documentation committee subjective knee form	Patient-reported measure of knee symptoms, function and activity level, scored 0-100	2 years after ACLR
Secondary	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	2 years after ACLR
Secondary	Adherence/fidelity to the intervention	Project-specific questionnaire	Monthly self-report 7-14 months after ACLR
Secondary	Barriers and motivating factors for adherence to the intervention	Self-reported on a project-specific questionnaire	14 months after ACLR