Femoral FractureSERRENCT05087667
Study of the Effectiveness of a Polymer Cerclage System Compared to Cerclages Used in Standard Care (CERCPMCF) )
A study testing Implantation of Ortholoop cerclage and Implantation of Cerclage used in current practice in people with Femoral Fracture, run by Quanta Medical at 15 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Fracture
- What is being tested?
- Implantation of Ortholoop cerclage and Implantation of Cerclage used in current practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 15 sitesFrance
- Study dates
- 8 Mar 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient with femoral or humeral fracture requiring the installation of one or more cerclage(s) and respecting at least one of the criteria below:
- Primary femoral or humeral fractures (diaphyseal, metaphyseal, epiphyseal proximal or distal) with osteosynthesis by plate and screw or osteosynthesis by Intramedullary nailing associated with the installation of one or more cerclage(s)
- Patients with traumatic fracture of femur or humerus that required prosthetic rehabilitation associated with the installation of one or more cerclage(s)
- Peri-prosthetic fracture of the femur or humerus
- Resumption of prosthesis (hip, knee, shoulder, elbow) requiring the installation of one or more cerclages
- who underwent fixation with cerclage wiring (Sterile Self Locking Polymer Cerclage System or other cerclage systems used in standard care)
Show all 10Show fewer
- age ≥18 years
- Who have given free, informed and written consent to participate in the study
- Patient able to communicate in French
- Patient affiliated to a social security system or entitled to a social security system
Who cannot join
- high-energy injury,
- associated damage to other long bones,
- fracture extension to the articular surface with displacement
- Severe disease that could interfere with the study results or be life threatening
- Patients with an infection
- Allergy to any component of the medical products
Show all 11Show fewer
- Pregnant or breastfeeding women
- Anticipated unavailability during the study
- Participation in a clinical trial within 3 months prior to the inclusion visit.
- Patient with linguistic or psychological incapacity to understand and sign the informed consent.
- Patient deprived of liberty by administrative or judicial decision, or being under guardianship.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites, 11 recruiting
- Recruiting
Clinique ESQUIROL SAINT HILAIRE
Agen, France, 47000
Damien LAQUES, Dr
- Recruiting
CH Agen
Agen, 47000
Adrian BACIULESCU, Dr, 0623900370, baciulescua@ch-agen-nerac.fr
- Active, not recruiting
CH Arcachon
Arcachon, 33164
- Recruiting
Clinique de Saint Omer
Blendecques, 62575
Pierre-Emmanuel RIDON, Dr, 06 67 53 77 94, pierre.emmanuel.ridon@gmail.com
- Recruiting
CH Le Mans
Le Mans, 72037
Lilian COZMA, Dr, 06 30 11 26 86, lcozma@ch-lemans.fr
- Recruiting
CH Libourne
Libourne, 33505
Pierre MEYNARD, Dr, 06 74 77 66 19, pierre.meynard@ch-libourne.fr
- Recruiting
CHU Lille
Lille, Nord, 59000
Marc SAAB, Marc.SAAB@CHRU-LILLE.FR
- Recruiting
Ch Metz - Thionville
Metz, 57085
MBarek IRRAZI, Dr, 06 62 62 51 38, Mb.irrazi@chr-metz-thionville.fr
- Recruiting
CHRU Nancy
Nancy, 54000
Didier MAINARD, Pr, 03 83 85 17 82, didier.mainard@univ-lorraine.fr
- Terminated
CHU Nimes
Nîmes, 30900
- Not yet recruiting
Hôpital Privé Francheville
Périgueux, France, 24000
Guy AMSALLEM, Dr
- Recruiting
Polyclinique Du Parc
Saint-Saulve, 59880
Arnaud MULLIEZ, Dr, 03 27 23 92 79, amulliez@cliniqueduparc.com
- Terminated
CHU Toulouse
Toulouse, 31300
- Active, not recruiting
CH Tourcoing
Tourcoing, France, 59208
- Recruiting
CH Valenciennes
Valenciennes, 59300
Maciej SMOCZINSKY, Dr, 06 32 34 31 80, smoczynski-m@ch-valenciennes.fr
About this study
Official title: Outcomes of Adjuvant "Polymer Cerclage System "OrthoLoop" to Manage Prosthetic Rehabilitation, Per Prosthetic or Primary Femoral and Humeral Fractures. A Prospective , Multicentric, Simple Blind , Comparative, Non-inferiority Study, Compared to Cerclage Systems Used in Standard Care.
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.
Read more
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 :
- Experimental group: "OrthoLoop cercalge"
- Control group: "cerclages used in standard care" After each surgery, the patient follow-up period is 36 months. with 4 planned consultation visits after surgery at 6-8 weeks, 3, 6 and 36 months, with collection and measurement of the endpoints.
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.
- Conditions
- Femoral Fracture
- Being tested
- Implantation of Ortholoop cerclage, Implantation of Cerclage used in current practice
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of Ortholoop cerclageDevice
implantation of Sterile Self Locking Polymer Cerclage System named OrthoLoop to the patient and follow up for 36 months post-intervention
Implantation of Cerclage used in current practiceDevice
implantation of Cerclage used in current practice to patients and follow up for 36 months post-intervention
| Study group | Role | What they receive |
|---|---|---|
| Polymer Cerclage System OrthoLoop | Experimental | Patients receives Ortholoop Cerclage System Receives: Device: Implantation of Ortholoop cerclage |
| cerclages used in standard care | Active comparator | Patients receives cerclages used in standard care" Receives: Device: Implantation of Cerclage used in current practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- the ability to walk full weight bearing without pain at the fracture site, or return to normal, painless mobility at the fracture site,
- and radiographs showing signs of bony union with no rupture or migration of the cerclage.
Rupture or cerclage migration or nonunion or need for revision of the implant before 6 months is considered as failure.
Measured: 6 months post-surgery
Secondary outcomes (7)
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
Measured: 6 months post-surgery
Asses union time
Union time is defined as time from intervention until
- For Femoral fracture: ability of patient to walk full weight bearing without pain at the fracture site and radiographs showing signs of bony union
- For humeral fracture: The patient regained full mobility without pain at the fracture site.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: During surgery (at D0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start8 Mar 2022
- Primary completionJun 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Femoral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster's randomization
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 202 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quanta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cousin Biotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087667
- Sponsor's protocol ID
- 3069_CERCPMCF
- Acronym
- SERRE
- Status last verified
- Nov 2024
- First submitted
- 21 Sep 2021
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17477925Rayan 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.
PubMed 21157744Tsiridis 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.
PubMed 19462362Ferbert 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.
PubMed 31096789Ebraheim 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.
PubMed 24002835Angelini 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.
PubMed 26983607Gordon 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.
PubMed 27338228Angelini 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.
PubMed 25186972Altenburg 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.
PubMed 19571089Silverton 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.
PubMed 8792246Peeters 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.
PubMed 31326103
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Adjuvant "Polymer Cerclage System "OrthoLoop" to Manage Prosthetic Rehabilitation, Per Prosthetic or Primary Femoral and Humeral Fractures. A Prospective , Multicentric, Simple Blind , Comparative, Non-inferiority Study, Compared to Cerclage Systems Used in Standard Care.
- ClinicalTrials.gov ID
- NCT05087667
- Acronym / sponsor ID
- SERRE / 3069_CERCPMCF
- Conditions
- Femoral Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- Quanta MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Cousin Biotech
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- Experimental group: "OrthoLoop cercalge"
- Control group: "cerclages used in standard care" After each surgery, the patient follow-up period is 36 months. with 4 planned consultation visits after surgery at 6-8 weeks, 3, 6 and 36 months, with collection and measurement of the endpoints.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cluster's randomization
| Arm | Type | Receives |
|---|---|---|
| Polymer Cerclage System OrthoLoop | Experimental | Device: Implantation of Ortholoop cerclagePatients receives Ortholoop Cerclage System |
| cerclages used in standard care | Active comparator | Device: Implantation of Cerclage used in current practicePatients receives cerclages used in standard care" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- patient with femoral or humeral fracture requiring the installation of one or more cerclage(s) and respecting at least one of the criteria below:
- Primary femoral or humeral fractures (diaphyseal, metaphyseal, epiphyseal proximal or distal) with osteosynthesis by plate and screw or osteosynthesis by Intramedullary nailing associated with the installation of one or more cerclage(s)
- Patients with traumatic fracture of femur or humerus that required prosthetic rehabilitation associated with the installation of one or more cerclage(s)
- Peri-prosthetic fracture of the femur or humerus
- Resumption of prosthesis (hip, knee, shoulder, elbow) requiring the installation of one or more cerclages
Key exclusion criteria (11 listed)
- high-energy injury,
- associated damage to other long bones,
- fracture extension to the articular surface with displacement
- Severe disease that could interfere with the study results or be life threatening
- Patients with an infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of Ortholoop cerclageimplantation of Sterile Self Locking Polymer Cerclage System named OrthoLoop to the patient and follow up for 36 months post-intervention | Device | Polymer Cerclage System OrthoLoop |
| Implantation of Cerclage used in current practiceimplantation of Cerclage used in current practice to patients and follow up for 36 months post-intervention | Device | cerclages used in standard care |
Primary outcome
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
Time frame: 6 months post-surgery
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: * the ability to walk full weight bearing without pain at the fracture site, or return to normal, painless mobility at the fracture site, * and radiographs showing signs of bony union with no rupture or migration of the cerclage. Rupture or cerclage migration or nonunion or need for revision of the implant before 6 months is considered as failure.
7 secondary outcomes
Assess consolidation rate during 6 months post surgery
Time frame: 6 months post-surgery
Asses union time
Time frame: 3, 6 and 36 months post-surgery
Assess rupture and migration rate of the cerclage after surgery throughout the follow-up
Time frame: 3, 6 and 36 months post-surgery
Assess pain
Time frame: 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
Time frame: During the whole study (up to 36 months)]
Assess surgery characteristics
Time frame: During surgery (at D0)
Assess physicians satisfaction regarding the use of "Sterile Self Locking Polymer Cerclage System
Time frame: During surgery (at D0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Results publication: PubMed 17477925Lindahl 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.
- Results publication: PubMed 21157744Rayan 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.
- Results publication: PubMed 19462362Tsiridis 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.
- Results publication: PubMed 31096789Ferbert 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.
- Results publication: PubMed 24002835Ebraheim 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.
- Results publication: PubMed 26983607Angelini 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.
- Results publication: PubMed 27338228Gordon 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.
- Results publication: PubMed 25186972Angelini 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.
- Results publication: PubMed 19571089Altenburg 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.
- Results publication: PubMed 8792246Silverton 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.
- Results publication: PubMed 31326103Peeters 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of Ortholoop cerclage and Implantation of Cerclage used in current practice in people with Femoral Fracture, run by Quanta Medical at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Saab, Dr (+33 (0) 1 47 08 63 41, b.hill@quanta-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05087667, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.