Patients Demographics
Data was reviewed and analyzed from the patients who were diagnosed with a bone non-union and underwent our treatment protocol in the trauma center of Shanghai sixth people’s hospital from October 2018 to May 2019. Patients with pathological fractures, osteonosus, cancers, immune disorders, thrombocytopenia, platelet dysfunction, large bone defects exceeding 5 cm of diameter, infectious non-unions, and hypertrophic non-unions without any previous therapeutic intervention (e.g., dynamization, exchange nailing) were excluded from this protocol. This study was performed according to the standards of the Declaration of Helsinki. Patient consents to the treatment protocol were obtained accordingly.
Finally, data from a total of 7 males and 9 females with mean age of 41.2 years (ranging from 28 years to 61 years) was evaluated retrospectively in this study, and 3 cases (accounting for 18.8%) had a history of a previous open fracture. Six of them underwent more than one prior surgical interventions. Hypertension and diabetes were identified in 5 patients and had been controlled effectively. Causes of injury, localizations of non-union site, types of non-union and other details of the patients’ demographics were tabulated in Table 1.
Table 1
No. of patients | Sex | Age (year) | Affected side | Causes of injury | Previous Open fracture | Number of previous surgeries | Location of nonunion site | Types of non-union | Initial hardware | Chronic disease | Duration of non-union | Follow-up period |
1 | F | 46 | L | Traffic accident | | 2 | Femoral supracondyle | Atrophic | plate | hypertension | 18 | 16 |
2 | F | 47 | L | Traffic accident | | 1 | Tibial proximal segment | Oligotrophic | plate | | 24 | 14 |
3 | M | 43 | R | Fall | Y | 4 | Tibial mid-shaft | Oligotrophic | plate | | 16 | 18 |
4 | F | 61 | L | machinery accidents | | 1 | radial mid-shaft | Oligotrophic | plate | hypertension, diabetes | 18 | 15 |
5 | M | 38 | R | Fall | | 2 | Femoral mid-shaft | Oligotrophic | plate | | 16 | 14 |
6 | F | 36 | R | Traffic accident | Y | 2 | Tibial mid-shaft | Atrophic | plate | | 9 | 18 |
7 | M | 32 | L | Trip | | 1 | Clavicular mid-shaft | Oligotrophic | plate | | 18 | 12 |
8 | F | 29 | L | Sport injury | | 1 | Humeral mid-shaft | Oligotrophic | intramedullary nail | | 12 | 15 |
9 | F | 32 | R | Traffic accident | Y | 2 | Tibial mid-shaft | Atrophic | plate | | 20 | 12 |
10 | F | 56 | R | Fall | | 1 | Femoral mid-shaft | Oligotrophic | plate | hypertension, diabetes | 14 | 18 |
11 | M | 28 | L | Trip | | 1 | Clavicular mid-shaft | Oligotrophic | plate | | 15 | 12 |
12 | M | 31 | R | Fall | Y | 1 | femoral supracondyle | Oligotrophic | plate | | 15 | 16 |
13 | M | 31 | L | Traffic accident | | 1 | Tibial mid-shaft | Oligotrophic | intramedullary nail | | 12 | 18 |
14 | F | 56 | R | trip | | 1 | proximal humerus | Oligotrophic | plate | diabetes | 20 | 12 |
15 | M | 41 | R | Traffic accident | Y | 2 | Tibial mid-shaft | Oligotrophic | plate | | 12 | 20 |
16 | F | 52 | R | Sport injury | | 1 | tibial distal segment | Oligotrophic | plate | hypertension | 16 | 16 |
Surgical Procedures
Non-union was defined as a fracture that not consolidate for a minimum of 9 months without signs of healing for at least 3 months [17], and patients were assessed by radiological appearances (e.g., x-ray, CT, PET-CT), clinical symptoms (e.g., deformity, abnormal activities, infection) and laboratory targets (e.g., white blood cell count, erythrocyte sedimentation rate, C-reactive protein) to identify if a bone infection or an osteonosus exists.
The index surgeries were performed by the same surgical team. After anesthesia, 50 ml of autogenous blood was drawn from peripheral vein and was isolated by two-step centrifugation for the preparation of PRP (5ml). To avoid devascularization, the periosteum or soft tissues surrounding the non-union site was carefully protected when exposing. Radically debridement of intervening scar tissue between the non-union site and re-open of medullary canals were performed to allow rapid neovascularization and migration of osteogenic cells. The initial hardware was not removed routinely unless they were loosened or there were requirements for debridement, fixation revision or deformity correction. The bone defects caused by debridement was then filled with the paste mixed by DBM putty (Allomatrix, Wright Medical Technology, Inc. Memphis, TN, USA) and PRP at a ratio of 5:1. In patients with a big size of bone defect, allogeneic bone was used for volume augmentation if necessary, and the amount was determined by the size of the defect and the experience of surgeons (Fig. 1). An additional plate would be implanted depending on the demand of mechanical stability. After the placement of a suction drain, standard wound closure and pressure dressing were performed.
Postoperative Management And Follow-up
All patients were treated with perioperative antibiotic prophylaxis and were informed to quit smoking. Low-molecular weight heparin was given for 2 weeks for patients undergoing the lower extremity surgery. Anteroposterior and lateral position X-ray films were taken within 3 days postoperatively. Normally, the suction drain was kept for 2 days and was removed if the daily drainage volume was less than 30ml/24h. Otherwise, the suction drain would be persisted. However, this practice has been changed in 1 patient, his drain was removed on postoperative day 7 even though the last daily drainage volume was more than 45 ml. Passive and active range-of-motion without weight-bearing were encouraged for early rehabilitation within the first 4 weeks, and then weight-bearing and strengthening exercises were recommended depending on radiological findings. Patients were followed up at monthly intervals postoperatively for radiographic and clinical assessment of bony union, which was defined as the presence of bridging callus formation on at least 3 out of 4 cortices in two different planes and the ability to painless weight-bearing.
Outcome Measures And Statistics
Outcomes including the drainage time, postoperative complications and the time of bony union were reviewed from medical records and follow up data and were was summarized by descriptive statistics using SPSS 22.0 (Chicago, IL, USA). Postoperative complications include incision exudation, delayed wound healing or long-term disunion, superficial or deep infections, and graft rejection. Functional recovery was not assessed because there is a lack of a unified criterion when the affected limbs and localizations of non-union site were different between patients.