Evaluation of JuggerKnot Soft Anchor Behaviour and Bone Remodelling in Rotator Cuff Repair Surgery

Development and improvement of suture anchor design for tendon-to-bone fixation
has facilitated the advancement for arthroscopic shoulder surgery over the last
decade. Initially, metallic suture anchors were mainly used for soft tissue
reconstruction, and later bioabsorbable anchors were developped. Complications
that were encountered included loosening, migration, breakage, incarceration of
the implant within the joint, metallic artifacts during imaging studies,
interference during revision surgery, foreign body reaction, cyst formation,
and synovitis. The JuggerKnot is the next step in anchor design. It is a
coreless sleeve and suture construct made out of polyester, and it eliminates
the use of rigid implants. The implant is small and has very high pull-out
strength. However, no clinical studies have been conducted to evaluate the
behaviour of soft suture implants for rotator cuff repair regarding bone
remodelling, cyst formation and osteolysis after implantation, and their
possible association with clinical outcome.

To evaluate the 2.9 mm JuggerKnot Soft Anchor in arthroscopic rotator cuff
repair regarding (1) orientation, dimensions and remodelling of the bone tunnel
after anchor placement (e.g. cyst formation, osteolysis), (2) integrity of the
rotator cuff repair, (3) and patient subjective outcomes with 2 year follow-up.
Hypothesis: Our hypothesis is that rotator cuff repair using the JuggerKnot
Soft Anchor will result in radiological evidence of rotator cuff healing
without implant related complications while maintaining good clinical outcome.

Prospective cohort study with 2 year follow-up. Patients will be followed
untill 2 years postoperative. Preoepratieve setting is depending on the
treatment of the physician. After inclusion in the study patients will be
operated with the JuggerKnot device. After surgery, the postoperative
radiograph will be replaced for a CT scan to receive more information about the
integrity of the rotator cuff and the bone status. At 6 weeks, 3 months, 6
months, 1 year and 2 years patietns will be followed with the subjective
outcome scores.
At 1 year a CT scan with artrography will be made for information about the
cuff integrity and the bone remodelling.

Because all interventions we will apply are standard treatment of patients with
a symptomatic rotator cuff tear, risks and possible burdens are the same as
compared to the standard clinical situation. Postoperatively CT evaluation will
be used to evaluate bone tunnel orientation and remodelling instead of
conventional x-ray evaluation. To evaluate repair integrity a CT-arthrography
will be used at 1 year postoperative. Patients will receive an intra-articular
injection gadolineum contrast 30 minutes prior to the CT scan. This is the same
procedure as patients will undergo in the standard diagnostic phase for rotator
cuff tears.