Better and Safer Return to Sport

NCT04049292 | Unknown

• 1 other identifier: 2018/1886
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 2

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.

Conditions

Anterior Cruciate Ligament Injuries; Sport Injury

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Return to sport

  Participation in preinjury sport (yes/no)

  2 years after ACLR

• Reinjury

  Injury to the ACL, medial or lateral meniscus in the ipsi- and contralateral knee (yes/no)

  2 years after ACLR

Secondary Outcomes (4)

• International knee documentation committee subjective knee form

  2 years after ACLR

• Anterior cruciate ligament return to sport after injury

  2 years after ACLR

• Adherence/fidelity to the intervention

  Monthly self-report 7-14 months after ACLR

• Barriers and motivating factors for adherence to the intervention

  14 months after ACLR

Other Outcomes (2)

• Sports participation

  2 years after ACLR

• OSTRC overuse injury questionnaire

  2 years after ACLR

Study Arms (2)

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.

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

Other: Usual care

Interventions

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.

RTS and rehabilitation tool

Usual care OTHER

Usual care is determined by the treating health care professional

Usual care

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator
• International Olympic Committee: collaborator
• Swedish Research Council for Sport Science: collaborator
• Linkoeping University: collaborator
• Karolinska Institutet: collaborator

Study Sites (2)

Norsk Idrettsmedisinsk Institutt

Oslo, 0806, Norway

RECRUITING

Idrettens helsesenter

Oslo, Norway

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Hege Grindem, PT PhD

  Norwegian School of Sport Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tone Øritsland

CONTACT

+4723262367; t.h.oritsland@nih.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 8, 2019
• Study Start: March 27, 2019
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: March 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)