Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Cousin Biotech | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The use of cerclage wiring in the management of long bone fractures is common. With the increase in the placement of total hip ans shoulder prostheses, the occurrence of peri-prosthetic hip an shoulder fractures is also increasing, notably due to an older population.
Whether it is for a fracture on a native femur or humerus, or on a periprosthetic hip or shoulder fracture, the use of cerclage wiring is an adjuvant additional but not the main means to ensure stable osteosynthesis, allowing re-loading and early rehabilitation of patients. This method has demonstrated its ability to improve the fixation of this fracture type, associated with osteosynthesis or hip/shoulder prosthesis revision surgery. However, metal cerclage expose to a risk of metallosis which can compromise bone fusion, injury to neighboring soft parts causing pain and also injury to the surgical team when handling them. More recently, non-metallic cerclage have been developed and could overcome certain risks associated with metallic cerclage, while ensuring their bone fixing capacity and therefore bone consolidation. Indeed, non-metallic cerclage could withstand similar or even greater stresses than metallic cables, in particular concerning their resistance to rupture.
The "Sterile Self Locking Polymer Cerclage System" named OrthoLoop is a polymer cerclage which has been developed and could be used in these indications.
Thus, this study (SERRE) aims to investigate the clinical results and sequelae of adjuvant cerclage wires OrthoLoop Cerclage in the management of rehabilitation, per prosthetic or primary femoral or humeral fractures compared with cerclages system used in standard care.
SERRE is a 36 months follow up study in two arms :
The main objective of this study is to assess the role of "OrthoLoop cerclage" of COUSIN Biotech in comparison with cerclages (metallic for the majority) used in standard care ; in the optimization of the consolidation of primary and periprosthetic femoral or humeral fractures, 6 months after surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polymer Cerclage System OrthoLoop | Experimental | Patients receives Ortholoop Cerclage System |
|
| cerclages used in standard care | Active Comparator | Patients receives cerclages used in standard care" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of Ortholoop cerclage | Device | implantation of Sterile Self Locking Polymer Cerclage System named OrthoLoop to the patient and follow up for 36 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Assess role of Polymer Cerclage System OrthoLoop of COUSIN Biotech in comparison with cerclages (metallic for the majority) used in standard care; in the optimization of the consolidation of primary and periprosthetic fractures of long bones | primary endpoint will be success or failure 6 months after surgery: Success of "Sterile Self Locking Polymer Cerclage System" to optimize consolidation during 6 months post surgery is defined as:
Rupture or cerclage migration or nonunion or need for revision of the implant before 6 months is considered as failure. | 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Assess consolidation rate during 6 months post surgery | Consolidation (or union) is defined as the ability to walk full weight bearing without pain or return to normal, painless mobility at the fracture site , and radiographs showing signs of bony union | 6 months post-surgery |
| Asses union time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Saab, Dr | Contact | +33 (0) 1 47 08 63 41 | b.hill@quanta-medical.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique ESQUIROL SAINT HILAIRE | Recruiting | Agen | France | 47000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17477925 | Result | Lindahl H. Epidemiology of periprosthetic femur fracture around a total hip arthroplasty. Injury. 2007 Jun;38(6):651-4. doi: 10.1016/j.injury.2007.02.048. Epub 2007 May 2. | |
| 21157744 | Result | Rayan F, Haddad F. Periprosthetic femoral fractures in total hip arthroplasty - a review. Hip Int. 2010 Oct-Dec;20(4):418-26. doi: 10.1177/112070001002000402. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cluster's randomization
Not provided
Not provided
Single blinded study. The patient will be blinded from the randomization arm. As the procedure is performed under general anaesthesia, the patient will not be informed whether or not the Sterile Self Locking Polymer Cerclage System has been implanted as a result of the procedure.
| Implantation of Cerclage used in current practice | Device | implantation of Cerclage used in current practice to patients and follow up for 36 months post-intervention |
|
Union time is defined as time from intervention until
|
| 3, 6 and 36 months post-surgery |
| Assess rupture and migration rate of the cerclage after surgery throughout the follow-up | Rupture and migration of the cerclage are confirmed on X Ray imaging. | 3, 6 and 36 months post-surgery |
| Assess pain | Pain will be assessed using visual analog scale pain scores (VAS) from 0 to 100 (0 means no pain at all and 100 maximum pain) at each visit. | 6-8 weeks,3, 6 and 36 months post-surgery |
| To report the incidence of complications and their treatment, particularly with respect to the need of further surgery | Safety data during patients 36 months follow up are defined such as: Infection Neurovascular injury Allergic reaction Bone ischemia Irritation feeling | During the whole study (up to 36 months)] |
| Assess surgery characteristics | Surgery characteristics are: Rupture of cerclage during the surgery (at time of implantation) Number of wire cerclages used implant used for osteosynthesis (nail or plate) Using of screw fixation operative time | During surgery (at D0) |
| Assess physicians satisfaction regarding the use of "Sterile Self Locking Polymer Cerclage System | Physicians satisfaction regarding the use of "Sterile Self Locking Polymer Cerclage System" will be assessed on: Global satisfaction of the surgeon Ease of use Ancillaries (Cable Passer, Tensioner) : ease of use and lightweight Ease of tension control by the surgeon using tensioner Ease of tracking of the cerclage on radiography Resistance over time (at least until bone consolidation) Presentation (ease of unwinding, packaging) | During surgery (at D0) |
| Hôpital Privé Francheville | Not yet recruiting | Périgueux | France | 24000 | France |
|
| CH Tourcoing | Active, not recruiting | Tourcoing | France | 59208 | France |
| CHU Lille | Recruiting | Lille | Nord | 59000 | France |
|
| CH Agen | Recruiting | Agen | 47000 | France |
|
| CH Arcachon | Active, not recruiting | Arcachon | 33164 | France |
| Clinique de Saint Omer | Recruiting | Blendecques | 62575 | France |
|
| CH Le Mans | Recruiting | Le Mans | 72037 | France |
|
| CH Libourne | Recruiting | Libourne | 33505 | France |
|
| Ch Metz - Thionville | Recruiting | Metz | 57085 | France |
|
| CHRU Nancy | Recruiting | Nancy | 54000 | France |
|
| CHU Nimes | Terminated | Nîmes | 30900 | France |
| Polyclinique Du Parc | Recruiting | Saint-Saulve | 59880 | France |
|
| CHU Toulouse | Terminated | Toulouse | 31300 | France |
| CH Valenciennes | Recruiting | Valenciennes | 59300 | France |
|
| 19462362 | Result | Tsiridis E, Pavlou G, Venkatesh R, Bobak P, Gie G. Periprosthetic femoral fractures around hip arthroplasty: current concepts in their management. Hip Int. 2009 Apr-Jun;19(2):75-86. doi: 10.1177/112070000901900201. |
| 31096789 | Result | Ferbert T, Jaber A, Gress N, Schmidmaier G, Gotterbarm T, Merle C. Impact of intraoperative femoral fractures in primary hip arthroplasty: a comparative study with a mid-term follow-up. Hip Int. 2020 Sep;30(5):544-551. doi: 10.1177/1120700019849911. Epub 2019 May 17. |
| 24002835 | Result | Ebraheim NA, Sochacki KR, Liu X, Hirschfeld AG, Liu J. Locking plate fixation of periprosthetic femur fractures with and without cerclage wires. Orthop Surg. 2013 Aug;5(3):183-7. doi: 10.1111/os.12052. |
| 26983607 | Result | Angelini A, Battiato C. Combination of low-contact cerclage wiring and osteosynthesis in the treatment of femoral fractures. Eur J Orthop Surg Traumatol. 2016 May;26(4):397-406. doi: 10.1007/s00590-016-1761-3. Epub 2016 Mar 17. |
| 27338228 | Result | Gordon K, Winkler M, Hofstadter T, Dorn U, Augat P. Managing Vancouver B1 fractures by cerclage system compared to locking plate fixation - a biomechanical study. Injury. 2016 Jun;47 Suppl 2:S51-7. doi: 10.1016/S0020-1383(16)47009-9. |
| 25186972 | Result | Angelini A, Battiato C. Past and present of the use of cerclage wires in orthopedics. Eur J Orthop Surg Traumatol. 2015 May;25(4):623-35. doi: 10.1007/s00590-014-1520-2. Epub 2014 Sep 4. |
| 19571089 | Result | Altenburg AJ, Callaghan JJ, Yehyawi TM, Pedersen DR, Liu SS, Leinen JA, Dahl KA, Goetz DD, Brown TD, Johnston RC. Cemented total hip replacement cable debris and acetabular construct durability. J Bone Joint Surg Am. 2009 Jul;91(7):1664-70. doi: 10.2106/JBJS.G.00428. |
| 8792246 | Result | Silverton CD, Jacobs JJ, Rosenberg AG, Kull L, Conley A, Galante JO. Complications of a cable grip system. J Arthroplasty. 1996 Jun;11(4):400-4. doi: 10.1016/s0883-5403(96)80029-5. |
| 31326103 | Result | Peeters I, Depover A, Van Tongel A, De Wilde L. A review of metallic and non-metallic cerclage in orthopaedic surgery: Is there still a place for metallic cerclage? Injury. 2019 Oct;50(10):1627-1633. doi: 10.1016/j.injury.2019.06.034. Epub 2019 Jul 13. |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
Not provided
Not provided