Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04049292 |
Other study ID # |
2018/1886 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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