Clinical trial NCT04049292: Better and Safer Return to Sport
Official title: Better and Safer Return to Sport After Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Sport Injury
Keywords: anterior cruciate ligament
return to sport
anterior cruciate ligament reconstruction
rehabilitation
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: Norwegian Fund for Postgraduate Training in Physiotherapy
name: International Olympic Committee
name: Swedish Research Council for Sport Science
name: Linkoeping University
name: Karolinska Institutet
First posted: 2019-08-08
Enrollment: 250
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Return to sport
timeFrame: 2 years after ACLR
measure: Reinjury
timeFrame: 2 years after ACLR
Secondary outcomes:
measure: International knee documentation committee subjective knee form
timeFrame: 2 years after ACLR
measure: Anterior cruciate ligament return to sport after injury
timeFrame: 2 years after ACLR
measure: Adherence/fidelity to the intervention
timeFrame: Monthly self-report 7-14 months after ACLR
measure: Barriers and motivating factors for adherence to the intervention
timeFrame: 14 months after ACLR
Other outcomes:
measure: Sports participation
timeFrame: 2 years after ACLR
measure: OSTRC overuse injury questionnaire
timeFrame: 2 years after ACLR
Locations:
city: Oslo
country: Norway
facility: Norsk Idrettsmedisinsk Institutt
city: Oslo
country: Norway
facility: Idrettens helsesenter
Study officials:
affiliation: Norwegian School of Sport Sciences
name: Hege Grindem, PT PhD
role: PRINCIPAL_INVESTIGATOR
References: