DESIGN: Single-site, parallel, two-arm randomised controlled feasibility trial.
SETTING: A UK tertiary centre hospital.
PARTICIPANTS: Patients aged ≥70 years who were ambulating pre-injury requiring hospital admission (within 28 days of injury) with a type 1 lateral compression PFF.
INTERVENTIONS: The intervention group received sacral fracture fixation (cement augmentation±screw fixation) within 7 days of randomisation. Routine preoperative and postoperative care followed each surgical intervention. The control group received usual care consisting of analgesia, and regular input from the medical and therapy team.
PRIMARY AND SECONDARY OUTCOME MEASURES: The feasibility outcomes were the number of eligible patients, willingness to be randomised, adherence to allocated treatment, retention, data on the completeness and variability of the proposed definitive trial outcome measures, and reported adverse events.
RESULTS: 241 patients were screened. 13 (5.4%) were deemed eligible to participate. Among the eligible participants, nine (69.2%) were willing to participate. Five participants were randomised to the intervention group and four to the control group. The clinicians involved were willing to allow their patients to be randomised and adhere to the allocated treatment. One participant in the intervention group and two participants in the control group received their allocated treatment. All participants were followed up until 12 weeks post-randomisation, and had an additional safety follow-up assessment at 12 months. Overall, the proportion of completeness of outcome measures was at least 75%. No adverse events were directly related to the trial.
CONCLUSIONS: There were significant challenges in recruiting sufficient participants which will need to be addressed prior to a definitive trial.
TRIAL REGISTRATION NUMBER: ISRCTN16719542.
Material and Methods: This is a prospective case series conducted on patients who were diagnosed with type V osteochondral lesions of talus. All the cases were treated with arthroscopic debridement, microfracture, and PRGF injections. The patients were evaluated for the healing of subchondral cysts and progression of osteoarthritis with radiography (plain radiographs and computerised tomography Scan). Also, the patients' outcome was evaluated with Quadruple Visual Analogue Scale, Ankle Range of Motion, Foot and Ankle Disability Index, Foot and Ankle Outcome Instrument and a Satisfaction Questionnaire.
Results: Five male patients underwent arthroscopic debridement, microfracture and PRGF injection for type V osteochondral lesion of talus. The mean age of patients was 27.4 years (19-47 years). All the patients gave history of minor twisting injury. Subchondral cyst healing was achieved in all patients by six months post-surgery. However, four out of five patients had developed early osteoarthritic changes of the ankle by their last follow-up [mean follow-up 29 months (ranged 15-36 months)]. Despite arthritic changes, all the patients reported 'Good' to 'Excellent' results on satisfaction questionnaire and Foot and Ankle Disability Index and could perform their day to day activities including sports.
Conclusion: Arthroscopic debridement, microfracture, and PRGF causes healing of the subchondral cyst but does not cause cessation of progression to osteoarthritis of ankle in type V osteochondral defects of talus. However, despite progress to osteoarthritis, patient satisfaction post-procedure is good to excellent at short-term follow-up.