Failures, complications reported with resorbable devices

Three-year follow-up showed a 42% failure rate when the meniscal repair device was used in patients with intact ACLs.

Issue: July 2004

ByR.L. Randall, MD

This arrow device (top) broke during insertion when the cannula slipped off the meniscus, and pushed the implant into the capsule. The device was retrieved before continuing surgery. One of four arrow fixators used to repair a bucket handle tear of a 21-year-old woman’s medial meniscus broke at the junction of the shaft and barbs (bottom). A collegiate volleyball player, she had continual pain postop and locking when she returned to sport.

COURTESY OF CRAIG D. TIFFORD, PETER R. KURZWEIL

Researchers from Connecticut will no longer recommend a popular resorbable device used to repair meniscal tears because of a 28% failure rate and significant complications associated with it during arthroscopic procedures. Some implants broke or caused chondral scoring, they said.

Investigators implanted the Meniscus Arrow in 57 consecutive patients with 60 meniscal tears. The patients, who had bucket-handle tears meeting indications for the device, underwent arthroscopic meniscal repair done with a standard all-inside technique. The arrows were inserted manually rather than with the crossbow device provided in the instrument set, according to Craig D. Tifford, MD, who presented results at the Arthroscopy Association of North America 23rd Annual Meeting in Orlando, Fla.

The patients were followed up for at least three years (54 months, average).

Despite some encouraging reports with this device published in the literature, “Meniscal repair with the arrow led to postoperative problems in 37% of patients and a reoperation rate of 26%,” said Tifford, who is at NYCONN Orthopaedic and Rehabilitation Specialists in Stamford, Conn.

Conservative rehab

Average age of patients was 27 years old. In 42 patients whose anterior cruciate ligaments (ACLs) were torn, 45 ACLs were repaired at the time of the meniscal repair. Other arthroscopic concomitant procedures included one patient whose ACL was treated with radio frequency shrinkage and another with a tibial eminence fracture that needed fixation.

For rehabilitation, most patients did a modified, slow-paced program that involved toe touch weight-bearing on crutches for the first four weeks, Tifford said. Squatting was not permitted during the first four months, and at six months all patients resumed unrestricted activity. The first 10 patients, however, did an accelerated program, which was discontinued after it resulted in an unusually high failure rate, he said.

Patients whose repairs failed with the Arrow had symptoms such as sharp joint line pain and/or tenderness, and knee aches or effusion. If any of these symptoms occur “we feel that these are indications for a repeat surgery,” Tifford said.

“In patients who had concomitant ACL reconstruction, the failure rate was 20%. When the ACL was intact, there was a 42% failure rate,” Tifford said. Ten percent of patients had chondral scoring that was detected on arthroscopy. “The true incidence of this complication may be much higher as only those patients with failed repairs underwent repeat arthroscopy.”

Most failures occurred at or after four months, a time by which the authors of other studies using the Meniscus Arrow report that healing is complete or nearly complete, he said.

The Meniscus Arrow is manufactured by Linvatec, Largo, Fla.

For more information:

Kurzweil PR, Ignacio EM, Tifford CD. Clinical results of meniscal repair using the Bionx Arrow. #SS-26. Presented at the Arthroscopy Association of North America 23rd Annual Meeting. April 22-25, 2004. Orlando, Fla.