Table 5.
Adverse events as reported by patients
| Patient ID | Adverse event description | Onset date |
|---|---|---|
| 001 | Fell using crutches, stuck splint at study ankle | 12 March 2012 |
| Slipped on stairs, muscles sore at ankle | 11 May 2012 | |
| Development of stress fracture at calcaneus of study foot (osteoporosis-Z-score-3.7, severely osteoporotic) | Noted during May 2012 | |
| Small clot with superficial phlebitis right ankle | Noted during 17 May 2012 appointment | |
| Severed ACL right leg (study side) | Noted during unscheduled visit 18 July 2012 | |
| Fell off bike, landed on right side (knee area) | Early August 2012 | |
| Occasional catching and locking symptoms study ankle | Noted during 24 August 2012 visit | |
| Medial pain, study ankle | Noted during 24 August 2012 visit | |
| Dropped 1-lb weight on study ankle | Noted during 24 August 2012 visit | |
| 002 | Right hip replacement | 6 March 2013 |
| Continued pain left study ankle. Bony prominence subtalar joint noted during May 9 follow-up—patient had injection for this | Noted during unscheduled visit 4 April 2013 | |
| 003 | Cast causing pain—removed and replaced | Noted during unscheduled visit 23 October 2012 |
| Sharp, acute pain right study ankle | 5 November 2012 | |
| Shooting pains medial ankle, decreased sensation throughout entire dorsum of foot | Noted during 15 November 2012 visit | |
| Patient notes colour difference right study ankle, swelling in foot, lump on bottom of foot (noticed during December 2012), sore big toe with pain radiating to foot, numbness | Noted during unscheduled visit 21 December 2012 | |
| Severe OA left knee—referred to specialist | Referral 27 December 2012 | |
| After short walk, sharp pain in ankle | 6 January 2013 | |
| Corneal surgery for displaced lens | 10 January 2013 | |
| 004 | Graft not contained as well as hoped | Noted during 7 June 2012 visit |
| Stiff ankle | Noted during 12 July 2012 | |
| Ankle becomes swollen after running any distance | Noted during 15 November 2012 visit | |
| 005 | Slipped in elevator, caught himself | 24 June 2012 |
| Patient notes occasional numb/tingling sensation | Noted during 25 June 2012 visit | |
| Residual material back of joint | Noted during 25 June 2012 visit | |
| Dropped brick on ankle | 16 August 2012 | |
| Withdrawal symptoms from discontinuation of tramadol—insomnia, loss of appetite | Noted during 30 August 2012 visit |