Permissive weight bearing in trauma patients with fracture of the lower extremities

The development of surgical fracture care boosted 50 years ago and is improving since, while emphasis on post-surgical care facilitating optimal bone healing and function restoration remains sparse. The positive effects of early weight bearing, both for fracture healing and for maintaining muscle and bone mass, are well known. However, little is known about the association between the amount or timing of weight bearing and bony consolidation or functional recovery. As a result, weight bearing rehabilitation is often cautious and led by existing dogmas, such as the fear for secondary dislocation of the fracture or failure of a mechanical construct. We have developed an early permissive weight bearing post-surgery rehabilitation protocol, where progression of weight bearing is guided by the subjective experience (e.g. pain, weight bearing tolerance) of the patient and therapist, and objective parameters (e.g. temperature, edema, using insoles) are registered. This protocol is based on our clinical experience focused on patient centered rehabilitation and has been validated and implemented in Adelante rehabilitation centre since 2005. Retrospectively we retrieved the medical records and recorded the complications during the time phase the new protocol was used. We found a complication rate of 10 percent. We developed a treatment- and evaluation protocol for permissive weight bearing (PROMETHEUS protocol, see appendix A) to document and to record the weight bearing milestones (e.g. walking with 2 crutches, walking with 2 canes, walking with one cane and walking without any walking aids) in a database. We started practicing the PROMETHEUS protocol method guided by subjective experience of patient and therapist and objective parameters. Hereby, the therapy progression is measured in quality of performing an activity (walking) and not in percentage of bodyweight or in kilogram load bearing. In this proposal we want to compare our new protocol (PROMETHEUS) to the existing AO treatment guidelines in a prospective multi-center trial. This study will be performed in patients with peri- or intra-articular fractures of the pelvis and lower extremity after surgical treatment in which existing protocols do not allow early full weight bearing in the first 6-12 weeks.

Hypothesis 1: 1A; Included patients have better early recovery at function level (as measured with the Brunnstrom Fugl-Meyer (BFM) test), 1B; better outcome at activity level (as measured with the Lower Extremity Functional Scale (LEFS)), 1C; better participation (as measured with the SF-36) and 1D; a better quality of life (as measured with the EQ-5D-5L) in the first 6 months post-surgery when they are treated according to the permissive weight bearing protocol compared to patients treated according to standard AO guidelines. It is expected that long-term (1 year) functional outcome will be similar between the treatment groups and will be not the primary aim of this study. We have chosen for these three scales to cover the major outcome levels in the ICF model.18



Hypothesis 2: The permissive weight bearing protocol results is more cost-effective compared to the restricted weight bearing protocol and current guidelines.



Hypothesis 3: The rate of complications (e.g. failure of osteosyntheses, secondary displacement of fracture parts, non-union, infections) is equal or lower in patients who are treated according to the permissive weight bearing protocol compared to patients treated according to standard AO guidelines in the surgery reference.

The subjects have to complete questionnaires in week 0,1,3,6,12,26. After 6 months the follow-up will be ended.

Permissive weight bearing group: Treatment according to the PROMETHEUS protocol (treatment- and evaluation protocol), patients will have an optimal/intensive weight bearing treatment. The protocol contains a number of weight bearing milestones (e.g. walking with 2 crutches, walking with 2 canes, walking with one cane and walking without any walking aids). The treating physiotherapist or physician records the date these milestones are reached in the study database.