Study: NCT00529958

Adverse event: Failed Meniscal Repair
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Requiring repeat surgery for medial meniscal tears. There were no lateral meniscal tears.
Frequency: 2 affected / 110 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Intra-articular scarring requiring repeat surgery, caused by generalized arthrofibrosis (1), Cyclops lesions (4), or graft hypertrophy causing impingement (4).
Frequency: 4 affected / 110 at risk

Adverse event: Muscle injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hamstring injuries on the ipsilateral side, include hamstring strain (18 patients) and a hamstring tear (1 patient with a patellar tendon graft; tear due to a major traumatic event while wakeboarding).
Frequency: 1 affected / 110 at risk

Adverse event: Tibial Periostitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Diagnosed as pain, swelling, redness and tenderness isolated to the medial tibial surface, distinct from pain in the knee. All presented within 2 weeks post-operatively; all successfully treated with nonsteroidal anti-inflammatory drugs (NSAIDS)
Frequency: 1 affected / 110 at risk

Adverse event: Deep Wound Infection
Serious: no
Organ System: Infections and infestations
Notes: Treated successfully with IV and oral antibiotics
Frequency: 1 affected / 110 at risk

Adverse event: Sensory Nerve Problems
Serious: no
Organ System: Nervous system disorders
Notes: Related to graft harvest/portal incisions (5 patients) or as a result of medial meniscal repair (3 patients); treated with topical NSAIDs cream and corticosteroid injections. All problems were resolved except one resulting in long-term dysesthesia.
Frequency: 4 affected / 110 at risk

Adverse event: Stitch abscess
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 110 at risk

Adverse event: Meniscal Cyst
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Patellar Tendinopathy
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Chondral Lesion
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Requiring surgery.
Frequency: 1 affected / 110 at risk

Adverse event: Persistent Effusion/Inflammation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Arthritis bacterial
Serious: yes
Organ System: Infections and infestations
Notes: Detected 1 month post-operatively; treated with arthroscopic washout, intravenous antibiotics and successful preservation of the graft. Coagulase-negative Staphylococcus was the identified organism. Complete resolution.
Frequency: 1 affected / 110 at risk

Adverse event: Failed Meniscal Repair
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Requiring repeat surgery for medial meniscal tears. There were no lateral meniscal tears.
Frequency: 6 affected / 110 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Intra-articular scarring requiring repeat surgery, caused by generalized arthrofibrosis (1), Cyclops lesions (4), or graft hypertrophy causing impingement (4).
Frequency: 2 affected / 110 at risk

Adverse event: Muscle injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hamstring injuries on the ipsilateral side, include hamstring strain (18 patients) and a hamstring tear (1 patient with a patellar tendon graft; tear due to a major traumatic event while wakeboarding).
Frequency: 6 affected / 110 at risk

Adverse event: Tibial Periostitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Diagnosed as pain, swelling, redness and tenderness isolated to the medial tibial surface, distinct from pain in the knee. All presented within 2 weeks post-operatively; all successfully treated with nonsteroidal anti-inflammatory drugs (NSAIDS)
Frequency: 2 affected / 110 at risk

Adverse event: Superficial Wound Infection
Serious: no
Organ System: Infections and infestations
Notes: Successfully treated with oral antibiotics.
Frequency: 2 affected / 110 at risk

Adverse event: Sensory Nerve Problems
Serious: no
Organ System: Nervous system disorders
Notes: Related to graft harvest/portal incisions (5 patients) or as a result of medial meniscal repair (3 patients); treated with topical NSAIDs cream and corticosteroid injections. All problems were resolved except one resulting in long-term dysesthesia.
Frequency: 1 affected / 110 at risk

Adverse event: Stitch abscess
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Persistent Effusion/Inflammation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 110 at risk

Adverse event: Massive Pulmonary Embolism
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Identified at 2 weeks post-operatively; treated successfully with anticoagulation and an IVC filter with no long-term sequelae. Complete resolution.
Frequency: 1 affected / 110 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Identified 18 days post-operatively; treated successfully with anticoagulant therapy with no clinical sequelae.
Frequency: 1 affected / 110 at risk

Adverse event: Failed Meniscal Repair
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Requiring repeat surgery for medial meniscal tears. There were no lateral meniscal tears.
Frequency: 4 affected / 110 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Intra-articular scarring requiring repeat surgery, caused by generalized arthrofibrosis (1), Cyclops lesions (4), or graft hypertrophy causing impingement (4).
Frequency: 3 affected / 110 at risk

Adverse event: Muscle injury
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Hamstring injuries on the ipsilateral side, include hamstring strain (18 patients) and a hamstring tear (1 patient with a patellar tendon graft; tear due to a major traumatic event while wakeboarding).
Frequency: 12 affected / 110 at risk

Adverse event: Tibial Periostitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Diagnosed as pain, swelling, redness and tenderness isolated to the medial tibial surface, distinct from pain in the knee. All presented within 2 weeks post-operatively; all successfully treated with nonsteroidal anti-inflammatory drugs (NSAIDS)
Frequency: 4 affected / 110 at risk

Adverse event: Superficial Wound Infection
Serious: no
Organ System: Infections and infestations
Notes: Successfully treated with oral antibiotics.
Frequency: 2 affected / 110 at risk

Adverse event: Sensory Nerve Problems
Serious: no
Organ System: Nervous system disorders
Notes: Related to graft harvest/portal incisions (5 patients) or as a result of medial meniscal repair (3 patients); treated with topical NSAIDs cream and corticosteroid injections. All problems were resolved except one resulting in long-term dysesthesia.
Frequency: 3 affected / 110 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 110 at risk

Adverse event: Wound dehiscence
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 110 at risk

Adverse event: Chondral Lesion
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Requiring surgery.
Frequency: 1 affected / 110 at risk

Adverse event: Persistent Effusion/Inflammation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 5 affected / 110 at risk