Acute anterior cruciate ligament rupture: RecOnsTruction Or Repair?

An anterior cruciate ligament rupture is a serious injury to the knee with high
probability of the occurrence of dynamic instability, accompanying lesions and
early post-traumatic arthrosis. Despite conservative treatment through
rehabilitation or ACL reconstruction surgery not all patients do return to
their previous activity levels. Moreover degenerative changes, especially early
posttraumatic arthrosis, are not counteracted.
In order to optimize the clinical results after ACL surgery, a renewed interest
has emerged in healing the patient's own ruptured ACL after attaching.
Literature suggests that with the current innovations in surgical repair
techniques of (natural) healing of a ruptured ACL may result in similar
clinical outcomes in comparison to the gold standard, the ACL reconstruction.
In addition, it may even reduce degenerative changes occur in relation to the
gold standard. Moreover, the return to daily activities and sports level seems
significantly faster than after ACL reconstruction.
The hypothesis is that a suture (suture repair) of a ruptured ACL, combined
with a dynamic intraligamentary stabilization, as well as microfracture of the
femoral notch, passes, at least equal efficacy in comparison with an anterior
cruciate ligament reconstruction using autologous hamstrings in terms of
functional recovery 1 years postoperatively.
The DIS bonding technique will be applied in the current study to surgically
repair (suture) the ruptured ACL. DIS is an abbreviation and stands for
intraligamentary dynamic stabilization (DIS). DIS has been used in humans and
seems to provide a high patient satisfaction, favorable clinical and
radiological results. However, to our knowledge, to date, no randomized
comparative study has been conducted yet in which the DIS technique is compared
with the gold standard, the ACL reconstruction.

Primary goal:
Investigate the hypothesis that suture repair of a ruptured vkb, combined with
a dynamic intraligamentary stabilization and microfracture of the femoral
notch, results in at least equal effectiveness compared with an ACL
reconstruction using autologous hamstring in terms of functional recovery one
year postoperatively in terms of a patient self-reported outcome related to be
able to conduct daily and sporting activities.

Secondary objective:
Evaluation of clinical outcomes - including isokinetic force- and jump tests,
instrumented jump tests 1 and 2 years post-operative and an instrumented
sport-specific fatigue test including jump tests (in a subgroup (n=6-8) between
10-18 months after repair surgery) -, self-reported by the patient outcomes,
osteoarthritis, rehabilitation time required for return to daily and sporting
activities and levels of sporting activity which has returned in patients with
status after an ACL rupture and suture repair augmented with a dynamic
intraligamentary microfracture and stabilization of the femoral notch in
comparison with an anterior cruciate ligament reconstruction with the
ipsilateral hamstring graft.

This study is a single center stratified block randomized controlled trial.
Patients with ACL rupture, confirmed by an orthopedic surgeon based on the
outpatient history and radiographic images, will be randomized into an
experimental ('repair' / DIS) group after inclusion and a control
(reconstruction, regular care) group. Patients will be stratified on the level
of sport/physical active practice, on the basis of the Tegner score. The Tegner
score is an evaluative and inventory questionnaire on which the patient
indicates the gravity of his work and/or sports activities. A higher score is
associated with a higher level of physical strain/activity . On the basis of
the Tegner score patients will be stratified into a 'moderate' physically
active stratum (group Tegner score 5-6-7) and 'highly' physically active
stratum (group Tegner score 8 -9-10). Stratification based on the degree of
physical activity is considered to be important because the extent and severity
of physical activity/strain in daily life poses a potential (difference) in
risk of re-rupture between the two study arms. In order to minimize potential
differences in 'exposure' or 'risk of re-rupture' between the two study groups
stratification is relevant.Measurements take place at baseline, peri-operative
/ immediately after surgery, 6 weeks, 3,6,9 months and 1, 2, 5 and 10 years
postoperatively. The instrumented jump tests take place at 1 en 2 years
follow-up. The sport-specific fatigue test (in which the patient has to run and
pivoting for 4x15 minutes about a distance of 20 meters started with, every 15
minutes alternating with, and ending with jump tests (drop vertical jump,
single leg hop and hold, triple hop for distance, both legs)) will take place
within 6 months after 1 year follow-up.

n=48 patients will participate in the current study. n=33 at OCON and n=15 at
HAGA. Patients will be assigned to a suture repair of the ruptured vkb
complemented by a dynamic intraligamentary stabilization (DIS) and
microfracture of the femoral notch or the gold standard, a ACL reconstruction.

Patients are asked preoperative, perioperative / immediate postoperative, 6
weeks postoperatively, 3,6,9 and 12 months postoperatively, 2.5 and 10 years
postoperatively to fill out a questionnaire booklet and undergo clinimetric
testing by a sports physiotherapist. Compared with usual care, only the time
points 5 and 10 years postoperatively are an additional burden for patients.

- 5x questionnaires subjective IKDC, KOOS, Tegner and VAS (estimated completion
time 10 minutes). The questionnaires will be taken digitally. In addition, the
WAI shortened measurement will be filled in any time point, we do not use it in
the regular care.
- 5x clinimetrics: IKDC physical examination, instrumented AP laxity, LSI
jump-force testing, instrumented jump tests and sport-specific fatigue test.
The clinimetric tests (except the sport-specific fatigue test) will be executed
by an experienced and specialized ACL sports physiotherapist. The total time
for instruction, conducting, and documenting these tests will vary from person
to person but is estimated at a maximum of 35 minutes. The instrumented jump
tests requires an estimated additional duration of 10 minutes to attach the
sensors. The sport-specific fatigue test will take a maximum of 2 hours per
person. There is no risk during the fatigue test, as the measurements consist
of movements during normal sport activities.
- Compared to regular care two additional x-ray pictures will be taken in the
context of the study (on 5 and 10 years postoperatively). A subset of 6-8
patients between 10-18 months after repair surgery will undergo a
sport-specific fatigue test.

Preparation, duration of surgery (both at 45 minutes) and directive to dismiss
will be equal for both groups. In addition, patients who decide to participate
in the current study must be willing to comply with a post-operative
rehabilitation trajectory at a sports physiotherapist (average of 2 times per
week).

Patients in the repair group can be upon request of the patient (in the absence
of an medical indication) re-operated during day surgery (spinal aneasthesia)
to remove the fixation screw of the DIS ligament. After surgery, patients are
recommend a full weight bearing protocol postoperatively (guided by the pain).
The removal will occur after the 12 months control moment of the study.