The safety, efficacy and cost-effectiveness of the Maxm Skate, a lower limb rehabilitation device for use following total knee arthroplasty: study protocol for a randomised controlled trial.

BACKGROUND: Physical rehabilitation is required to enhance functional outcomes and overall recovery following total knee arthroplasty (TKA). However, there are no universally accepted clinical guidelines available to consistently structure rehabilitation for TKA patients. A common method is rehabilitation provided in an outpatient setting, on a one-to-one treatment basis. This method is resource-intensive and outcomes must be compared to less costly alternatives such as home-based rehabilitation. The current study will analyse a novel home-based rehabilitation program. The Maxm skate is a portable, lower-limb, postoperative, rehabilitation exercise device for individual use in a hospital or home-based setting. This study was developed to compare the safety, efficacy and cost-effectiveness of the Maxm Skate rehabilitation program to standard rehabilitative care following TKA. The primary outcome is the range of motion (ROM) achieved by patients who received the Maxm Skate program compared to standard care at three months post TKA. Secondary outcomes include patient-reported outcomes, costs and functional evaluations which will be collected at multiple time-points up to 12 months after TKA. METHODS: This is a single-blinded, randomised controlled trial (RCT) in which 116 eligible participants consented for primary TKA will be randomly allocated to receive either the Maxm Skate rehabilitation program or standard rehabilitative care. Fifty-eight participants per group will provide 90% power (α = 0.05) to detect 10° of difference in ROM between groups at three months after TKA, assuming a within-group standard deviation of 16° and allowing for 5% loss to follow-up. Participants randomised to the Maxm Skate group will use the skate device and accompanying iOS App and sensors to complete rehabilitation exercises, as outlined in the Maxm Skate Rehabilitation Guide. Outcomes will be compared to those receiving standard rehabilitative care. A blinded physiotherapist will evaluate functional outcomes preoperatively and at 2, 4, 6, 12, 26 and 52 weeks after TKA. The functional assessment will include measures of knee ROM, pain, isometric knee strength, balance and knee/thigh circumference. Limited measures will also be assessed at day 2 postoperatively by an alternate, unblinded physiotherapist. Clinical outcome measures will be administered preoperatively and at 6, 12 and 52 weeks postoperatively. An economic evaluation will be conducted and participants will be screened for adverse event occurrences from the time of consent to 12 months postoperatively. DISCUSSION: This RCT will be the first to investigate the safety, efficacy and cost-effectiveness of the home-based Maxm Skate Rehabilitation program, in comparison to standard rehabilitative care following primary TKA. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12616001081404p . Registered on 11 August 2016.

Return to Play and Player Performance After Anterior Cruciate Ligament Injury in Elite Australian Rules Football Players.

BACKGROUND: Australian Rules football is a highly aerobic and anaerobic game that at times requires players to perform cutting or pivoting maneuvers, potentially exposing them to anterior cruciate ligament (ACL) injury. At present, there are limited data available addressing the impact of ACL injury on return to play and preinjury form after ACL reconstruction. PURPOSE: To determine the prevalence of ACL injury and the incidence of further ACL injury, and to consider player return to play and return to preinjury form after ACL reconstruction. It was hypothesized that elite-level Australian Football League (AFL) players do not return to preinjury form until, at minimum, 2 years after returning to play. STUDY DESIGN: Case series; Level of evidence, 4. METHODS: A retrospective analysis was undertaken on a cohort of elite AFL players who injured their ACL between 1990 and 2000. Return to play after ACL reconstruction was determined by the mean number of ball disposals, or release of the ball by the hand or foot, at 1, 2, and 3 years after return to play and compared with preinjury form. Associations between player and injury characteristics, method of reconstruction, and outcomes (return to play, preinjury form, and further ACL injury) were examined. RESULTS: During the included seasons, a total of 2723 AFL players were listed. Of these, 131 (4.8%) sustained an ACL injury, with 115 players eligible for inclusion. Of 115 players, 26% did not return to elite competition, while 28% of those who did return experienced further ACL injury. The adjusted mean number of disposals (± standard error of the mean) was significantly lower at 1 year (12.21 ± 0.63; P = .003), 2 years (12.09 ± 0.65; P = .008), and 3 years (11.78 ± 0.77; P = .01) after return to play compared with preinjury (14.23 ± 0.67). On average, players did not return to preinjury form by 3 years (P < .01). Players aged 30 years or older were less likely to return to play compared with younger players (P = .0002), moderate-weight players were more likely to return to play compared with lighter-weight players (P = .007), and there were significantly increased odds of not returning to play if the dominant side was injured (odds ratio, 0.10; 95% CI, 0.03-0.34; P = .0002). CONCLUSION: On average, AFL players do not return to their preinjury form after ACL injury and reconstruction, a common injury in this sporting population. This along with the high occurrence of reinjury highlights the career-threatening nature of ACL injury for elite AFL players.

Arthroscopic Chondral Debridement Using Radiofrequency Ablation for Patellofemoral Compartment Pathology.

The purpose of this Technical Note is to introduce a surgical technique using a fluid pressure pump, mid-lateral portal, and radiofrequency ablation for visualization, assessment, and subsequent, accurate/adequate removal of patellofemoral articular lesions for the treatment of patellofemoral compartment pathology. With the patient in the supine position, and an inflated thigh tourniquet, standard lateral and medial portals are made. The medial-femoral compartment, notch, lateral-femoral compartment, and patellofemoral compartments are assessed. If pathology is seen within the patellofemoral compartment, a mid-lateral portal is made if chondral pathology cannot be addressed thoroughly. Addressing chondral pathology to achieve chondral stability is then performed using a combination of the radiofrequency ablator and chondrotome. This technique provides greater visibility and access to accurately and thoroughly smooth chondral pathology.