Table 5

Protocol substantial amendments

Amendment/dateNature of amendmentRational
SA01
3 June 2015
  • Record maximum height and number of heel rises in HRET

  • Provide additional validation of the outcome measure

  • Ask patient which intervention they think they received in 24-week postassessment questionnaire

  • Assessment of success of blinding strategy

  • Stipulate guidelines for rehabilitation

  • To accommodate local preferences while ensuring the integrity and success of the trial

  • Added guidance if allocated intervention cannot be given

  • Guidance was omitted in original protocol version

  • Clarifications on the nature of the injury

  • Clarify injury type

SA02
8 March 2016
  • Change inclusion criteria

  • Increase upper age limit with requirement of ambulatory status

  • Increase recruitment period

  • 12 days postinjury instead of 7

  • Extended scope physiotherapists can administer the intervention

  • Pragmatic approach to accommodate for clinical practice

  • Clarification of the ATR diagnosis

  • Clarification of the rupture location

  • Clarification of anticoagulation

  • VTE prophylaxis requirement

  • Randomisation and statistical alterations

  • Approval of randomisation and statistical plan

SA03
21 April 2017
  • Extended 24 months follow-up

  • To study PRP on effect on the quality of the repaired Achilles tendon at 2 years postinjury

SA04
24 July 2017
  • Extend recruitment by 2 months

  • Increase sample size to 230

  • DSMC blinded interim data analysis found HRET SD is 24 with larger variability in data. Sample size increased to guarantee 80% power

  • ATR, Achilles tendon rupture; DSMC, Data and Safety Monitoring Committee; HRET, heel-rise endurance test; PRP, platelet-rich plasma; VTE, venous thromboembolism.