Overall Study Design
This multicenter, prospective controlled trial had recruitment sites in 9 hospitals in Beijing. The study was divided into three phases: 1) the protocol development phase, 2) the intervention phase, and 3) the follow-up phase. In the protocol development phase, we developed the team-based perioperative rehabilitation approach in the 9 hospitals and standardized the perioperative rehabilitation intervention and testing protocols. The trial was registered online, see http://www.chictr.org.cn/showproj.aspx?proj=5713 for more information, registered on 29 May 2013, registration number: ChiCTR-TCH-13003852.
Ethical Principles
Ethical approval was received from the ethics committees of the participating hospitals. Written informed consent was obtained from all participants before enrollment in the study.
Subjects
From January 2013 to December 2015, a total of 668 patients who underwent internal fixation surgery because of knee joint fracture were involved in this research. All patients were recruited from 9 medical centers.
Inclusion Criteria
1) Underwent open reduction and internal fixation because of femoral condyle fracture, patella fracture or tibial plateau fracture.
2) Aged 15 or older.
3) Had imaging results that showed a good fracture reduction and reliable internal fixation.
Exclusion Criteria
1) History of previous trauma, infection, tumor or congenital malformation that resulted in lower limb dysfunction.
2) Combined with open fracture, vascular or nerve injury, knee meniscus and ligament injury, fractures in the pelvis, or serious early complications after operation.
3) Combined with severe medical complications, such as heart failure, respiratory insufficiency, or kidney failure.
4) Severe psychiatric disease, cognitive disorder, or disturbance of consciousness not allowing the patient to cooperate with treatment.
Interventions
The patients were assigned to one of the two groups according to the patient's subjective intention (according to the suggestion by our institutional research ethics committee): the group that received the common postoperative treatments without involvement from rehabilitation clinicians (control group) or the group that received a team-based perioperative rehabilitation intervention in addition to the common postoperative treatments (trial group). And the group allocation outcomes were blinded to the research team members.
Control Group (CG)
The patients in the CG received common postoperative treatments provided by the orthopedic surgery team without any professional rehabilitation guidance.
Trial Group (TG)
The TG received both standard postoperative treatment and a team-based perioperative rehabilitation intervention. Rehabilitation clinicians, therapists, and orthopedic clinicians and nurses were included in the team responsible for the patients’ diagnosis, evaluation, treatment and rehabilitation. ① Rehabilitation clinicians and orthopedic clinicians with knowledge of both orthopedic surgery and rehabilitation theory had key roles in the team-based approach and were in charge of the program. The supervising clinicians were leaders in the perioperative rehabilitation team meetings, conducted evaluations, formulated rehabilitation targets and clinical pathways, decided the perioperative rehabilitation programs, decided discharged exercise plans, and were responsible for the follow-up. ② Rehabilitation therapist was the major executor who understood both orthopedic and rehabilitation treatment principles. The therapist formulated the rehabilitation program, performed daily rehabilitation training while the patients were in-hospital, and created specific home exercise plans together with the supervising clinicians. Patients were in-hospital for 3–4 days after surgery. During perioperative rehabilitation, the intervention was custom tailored according to the evaluation results. It was the therapist’s responsibility to report any changes in illness to the clinicians in time. ③ Nurse provided the patients with perioperative rehabilitation education and guidance, provided medical advice to the orthopedic rehabilitation team, and assisted the rehabilitation therapists in performing daily rehabilitation. The nurses in the team were required to have rehabilitation nursing knowledge and focus on perioperative care.
The tasks of the orthopedic rehabilitation team were as follows: ① The rehabilitation team held meetings before and after surgery to educate, evaluate, and decide on the rehabilitation program. ② The orthopedic rehabilitation team performed ward rounds once a day and recorded the data in the case report form. ③ The therapists and nurses implement rehabilitation treatments according to the clinical pathway. ④ The orthopedic rehabilitation team held a consultation prior to discharge and recorded the rehabilitation evaluation. ⑤ The supervising clinicians suggested individualized at-home exercise recommendations according to the evaluation results. ⑥ The team kept a record of the patients’ contact information, follow-up time and follow-up doctor.
One or two days before surgery, TG patients received perioperative rehabilitation education that aimed to help patients avoid anxious emotions, encourage patients to strengthen self-management, and teach correct training methods. In the early postoperative period, TG patients received routine postoperative treatment from the therapist according to the strategy decided by the orthopedic rehabilitation team. The treatment session lasted approximately 30 minutes each day and was performed under the guidance of rehabilitation therapists. The training content was focused on preventing early postoperative complications, including deep venous thrombosis, falls, muscle hypotrophy during no weight-bearing. The training program covered the following aspects: elevation of the affected limb, ankle pump, quadriceps isometric contraction, passive hip movement, standing on the unaffected lower limb under protection, range of motion (ROM), activity of daily life, etc.
Before discharge, TG patients receiving the team-based approach received a custom-tailored rehabilitation training guidebook and learned to continue the training at home. TG patients were required to perform endurance exercises at home for the next 6 months after surgery.
Outcome Measures
General patient characteristics including age, sex, height, weight and education background were collected. The operative information (recorded by the orthopedic surgeons in the operation records) included fracture site, blood loss, quality of anatomical reduction, and the stability of fracture fixation. The outcome measures used in this study included the visual analog scale (VAS) score, Hospital for Special Surgery (HSS) knee score and Berg Balance Scale (BBS) score. The VAS is widely and easily used to evaluate the pain in the back and limbs while resting or performing activity. VAS scores were assessed at 12 and 24 weeks (± 7 days) postsurgery. The HSS knee score and BBS scores are specific functional scales of lower limb function and are widely used worldwide. A higher HSS score indicates better knee function and the higher BBS score indicate better balance function. The HSS knee score and BBS score were assessed at 12 and 24 weeks (± 7 days) post-surgery.
Data Analysis
Continuous variables were described in terms of means and standard deviations, while ordinal variables and nominal variables were described in terms of percentages. The Shapiro-Wilk test was used to determine if the data were normally distributed. ANOVAs with repeated measures were used to examine the differences in the outcomes between groups. The Mann-Whitney U test was used to compare the two groups before and after surgery. The significance level was set at 0.05. An intention-to-treat (ITT) analysis was conducted, and the multiple imputation was used to input for missing data. The data were analyzed using SPSS for Windows, version 22.0 (SPSS Inc., Chicago, IL, USA).