Unstable Throchanteric Hip FracturesNCT07282236
Retrospective Comparative Outcomes of Gamma and InterTAN Nail for Unstable Intertrochanteric Hip Fractures
An observational study of Unstable Throchanteric Hip Fractures and Pertrochanteric Fracture of Femur, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
Trial summary
Objective: compare outcomes of unstable intertrochanteric hip fractures treated with two commercially available implants. Design: retrospective observational cohort of 288 treated with a Gamma® nail and 398 with an InterTAN® nail. Patients were operated between 1997 and 2010. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Unstable Throchanteric Hip Fractures, Pertrochanteric Fracture of Femur
- What is being tested?
- Fracture fixation with cephalomedullary nails
- Type of treatment
- Medical device
- How many people
- 686 participants
- Where
- 1 siteSpain
- Study dates
- 13 Dec 2025to 12 Jan 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who received the Gamma nail (288) underwent surgery at the Hospital Clínico Universitario, Valencia (1997-2002). On the other hand, the patients operated upon the InterTAN nail (398) underwent surgery at the Vithas Hospitals Group in Valencia between January 2002 and December 2010.
Who may be able to join
- Unstable trochanteric fractures confirmed radiographically according to OTA (Orthopedic Trauma Association), treated with Gamma or InterTAN nail,
- available follow-up for ≥ 6 months
Who cannot join
- Pathological fractures
- Polytrauma precluding standard treatment/follow-up
- Missing key variables/outcomes
Trial locations and contacts
1 site in 1 country.
Spain1 site
School of Medicine and Health Sciences, Valencia Catholic University
Valencia, VALÈNCIA, 46003
About this study
Official title: Quality of Reduction, Position of the Lag Screw and Mechanical Complications in Unstable Interthrochanteric Hip Fractures. A Comparison Between Gamma and InterTAN Nail.
Objective: compare outcomes of unstable intertrochanteric hip fractures treated with two commercially available implants. Design: retrospective observational cohort of 288 treated with a Gamma® nail and 398 with an InterTAN® nail. Patients were operated between 1997 and 2010. Primary outcomes: satisfactory reduction, optimal cephalic screw placement, and to evaluate the incidence of mechanical complications; secondary measures included the tip-apex distance (TAD), hematocrit (Hto) and hemoglobin (Hb) drop, transfusion requirement and volume, hospital length of stay and the time to first ambulation.
Read the detailed description
Rationale: to evaluate whether outcomes differ between two commonly used cephalomedullary nails for unstable intertrochanteric hip fractures in routine practice.
Setting: double-centre, single-city retrospective cohort with consecutive patients treated by the same surgeon-Gamma2® at the Hospital Clínico Universitario (1997-2002; n=288) and InterTAN® at Vithas Hospitals (2002-2010; n=398). Cohorts: defined by the implant used in usual care; adults ≥65 years with unstable AO/OTA A2-A3 patterns were included; key exclusions were stable patterns, pathologic fractures, subtrochanteric extension, poor radiographs, and <6-month follow-up. Planned analyses: between-group comparisons of reoperation and implant-related complications (primary focus), plus perioperative and functional parameters, using χ²/t-tests as appropriate adjusting for age, sex, ASA class, AO/OTA pattern, reduction quality, and screw position metrics (e.g., TAD); results reported as effect sizes with 95% CIs, with sensitivity analyses by fracture pattern and reduction quality
- Being tested
- Fracture fixation with cephalomedullary nails
- Keywords
- Throchanteric Fractures; Gamma nail; InterTAN nail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fracture fixation with cephalomedullary nailsDevice
No differences with the routine surgery for trochanteric fractures
| Study group | Role | What they receive |
|---|---|---|
| Gamma Nail Group | The Gamma Nail Group consists of patients diagnosed with unstable trochanteric fractures who underwent surgical management using a Gamma cephalomedullary nail. This intervention involves internal fixation with a short or long intramedullary device designed to provide stable biomechanical support for unstable peritrochanteric fracture patterns. Patients in this group received the Gamma nail as the primary method of fracture stabilization, with the goal of achieving early mobilization, maintaining fracture alignment, and reducing the risk of mechanical complication. Receives: Device: Fracture fixation with cephalomedullary nails | |
| InterTAN Nail Group | The InterTAN Nail Group includes patients with unstable trochanteric fractures who were treated surgically using an InterTAN cephalomedullary nail. This intervention consists of internal fixation with a dual integrated screw intramedullary device designed to enhance rotational and axial stability in unstable peritrochanteric fracture patterns. Patients in this group received the InterTAN nail as the primary method of fracture stabilization, aiming to improve construct rigidity, facilitate early mobilization, and support optimal fracture healing. Receives: Device: Fracture fixation with cephalomedullary nails |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant-related complications
Incidence of device-related adverse events (e.g., cut-out, varus collapse).
Measured: 6 months
Secondary outcomes (2)
Quality of fracture reduction
Satisfactory or unsatisfactory according to Baumgaertner's criteria
Measured: Immediately postoperative (within 24 hours)
Cephalic screw placement
Position of the lag screw according to Cleveland-Bosworth quadrants
Measured: Immediately postoperative (within 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start13 Dec 2025
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Unstable Throchanteric Hip FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 686 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282236
- Sponsor's protocol ID
- UCV/2022-2023/009
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Núñez JH, Moreira F, Surroca M, Martínez-Peña J, Jiménez-Jiménez MJ, Ocrospoma-Flores B, Castillón P, Guerra-Farfán E. Hip fractures in Spain. How are we? Systematic review and meta-analysis of the published registries. Rev Esp Cir Ortop Traumatol. 2024 Oct 16:S1888-4415(24)00156-5. English, Spanish. doi: 10.1016/j.recot.2024.09.010. Epub ahead of print. PMID: 39419269.
Werner M, Macke C, Gogol M, Krettek C, Liodakis E. Differences in hip fracture care in Europe: a systematic review of recent annual reports of hip fracture registries. Eur J Trauma Emerg Surg. 2022 Jun;48(3):1625-1638. doi: 10.1007/s00068-021-01797-8. Epub 2021 Oct 8.
PubMed 34623474Shankar KN, Li A. Older Adult Falls in Emergency Medicine, 2023 Update. Clin Geriatr Med. 2023 Nov;39(4):503-518. doi: 10.1016/j.cger.2023.05.010. Epub 2023 Jul 6.
PubMed 37798062Kalan Farmanfarma K, Yarmohammadi S, Fakharian E, Gobbens RJ, Mahdian M, Batooli Z, Lotfi MS, Abedzadeh-Kalahroudi M, Vatan RF, Khosravi GR, Fazel MR, Sehat M. Prognostic Factors of Hip Fracture in Elderly: A Systematic Review. Int J Prev Med. 2024 Aug 30;15:42. doi: 10.4103/ijpvm.ijpvm_169_23. eCollection 2024.
PubMed 39381356
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Reduction, Position of the Lag Screw and Mechanical Complications in Unstable Interthrochanteric Hip Fractures. A Comparison Between Gamma and InterTAN Nail.
- ClinicalTrials.gov ID
- NCT07282236
- Acronym / sponsor ID
- UCV/2022-2023/009
- Keywords
- Throchanteric Fractures; Gamma nail; InterTAN nail
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Study start
- 13 Dec 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 15 Dec 2025 (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.
Objective: compare outcomes of unstable intertrochanteric hip fractures treated with two commercially available implants. Design: retrospective observational cohort of 288 treated with a Gamma® nail and 398 with an InterTAN® nail. Patients were operated between 1997 and 2010. Primary outcomes: satisfactory reduction, optimal cephalic screw placement, and to evaluate the incidence of mechanical complications; secondary measures included the tip-apex distance (TAD), hematocrit (Hto) and hemoglobin (Hb) drop, transfusion requirement and volume, hospital length of stay and the time to first ambulation.
Detailed description
Rationale: to evaluate whether outcomes differ between two commonly used cephalomedullary nails for unstable intertrochanteric hip fractures in routine practice.
Setting: double-centre, single-city retrospective cohort with consecutive patients treated by the same surgeon-Gamma2® at the Hospital Clínico Universitario (1997-2002; n=288) and InterTAN® at Vithas Hospitals (2002-2010; n=398). Cohorts: defined by the implant used in usual care; adults ≥65 years with unstable AO/OTA A2-A3 patterns were included; key exclusions were stable patterns, pathologic fractures, subtrochanteric extension, poor radiographs, and <6-month follow-up. Planned analyses: between-group comparisons of reoperation and implant-related complications (primary focus), plus perioperative and functional parameters, using χ²/t-tests as appropriate adjusting for age, sex, ASA class, AO/OTA pattern, reduction quality, and screw position metrics (e.g., TAD); results reported as effect sizes with 95% CIs, with sensitivity analyses by fracture pattern and reduction quality
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gamma Nail Group | – | Device: Fracture fixation with cephalomedullary nailsThe Gamma Nail Group consists of patients diagnosed with unstable trochanteric fractures who underwent surgical management using a Gamma cephalomedullary nail. This intervention involves internal fixation with a short or long intramedullary device designed to provide stable biomechanical support for unstable peritrochanteric fracture patterns. Patients in this group received the Gamma nail as the primary method of fracture stabilization, with the goal of achieving early mobilization, maintaining fracture alignment, and reducing the risk of mechanical complication. |
| InterTAN Nail Group | – | Device: Fracture fixation with cephalomedullary nailsThe InterTAN Nail Group includes patients with unstable trochanteric fractures who were treated surgically using an InterTAN cephalomedullary nail. This intervention consists of internal fixation with a dual integrated screw intramedullary device designed to enhance rotational and axial stability in unstable peritrochanteric fracture patterns. Patients in this group received the InterTAN nail as the primary method of fracture stabilization, aiming to improve construct rigidity, facilitate early mobilization, and support optimal fracture healing. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who received the Gamma nail (288) underwent surgery at the Hospital Clínico Universitario, Valencia (1997-2002). On the other hand, the patients operated upon the InterTAN nail (398) underwent surgery at the Vithas Hospitals Group in Valencia between January 2002 and December 2010.
Key inclusion criteria (2 listed)
- Unstable trochanteric fractures confirmed radiographically according to OTA (Orthopedic Trauma Association), treated with Gamma or InterTAN nail,
- available follow-up for ≥ 6 months
Key exclusion criteria (3 listed)
- Pathological fractures
- Polytrauma precluding standard treatment/follow-up
- Missing key variables/outcomes
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 |
|---|---|---|
| Fracture fixation with cephalomedullary nailsNo differences with the routine surgery for trochanteric fractures | Device | Gamma Nail Group, InterTAN Nail Group |
Primary outcome
Implant-related complications
Time frame: 6 months
Incidence of device-related adverse events (e.g., cut-out, varus collapse).
2 secondary outcomes
Quality of fracture reduction
Time frame: Immediately postoperative (within 24 hours)
Cephalic screw placement
Time frame: Immediately postoperative (within 24 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Results publicationNúñez JH, Moreira F, Surroca M, Martínez-Peña J, Jiménez-Jiménez MJ, Ocrospoma-Flores B, Castillón P, Guerra-Farfán E. Hip fractures in Spain. How are we? Systematic review and meta-analysis of the published registries. Rev Esp Cir Ortop Traumatol. 2024 Oct 16:S1888-4415(24)00156-5. English, Spanish. doi: 10.1016/j.recot.2024.09.010. Epub ahead of print. PMID: 39419269.
- Results publication: PubMed 34623474Werner M, Macke C, Gogol M, Krettek C, Liodakis E. Differences in hip fracture care in Europe: a systematic review of recent annual reports of hip fracture registries. Eur J Trauma Emerg Surg. 2022 Jun;48(3):1625-1638. doi: 10.1007/s00068-021-01797-8. Epub 2021 Oct 8.
- Results publication: PubMed 37798062Shankar KN, Li A. Older Adult Falls in Emergency Medicine, 2023 Update. Clin Geriatr Med. 2023 Nov;39(4):503-518. doi: 10.1016/j.cger.2023.05.010. Epub 2023 Jul 6.
- Results publication: PubMed 39381356Kalan Farmanfarma K, Yarmohammadi S, Fakharian E, Gobbens RJ, Mahdian M, Batooli Z, Lotfi MS, Abedzadeh-Kalahroudi M, Vatan RF, Khosravi GR, Fazel MR, Sehat M. Prognostic Factors of Hip Fracture in Elderly: A Systematic Review. Int J Prev Med. 2024 Aug 30;15:42. doi: 10.4103/ijpvm.ijpvm_169_23. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unstable Throchanteric Hip Fractures and Pertrochanteric Fracture of Femur, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant-related complications (time frame: 6 months). 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 NCT07282236, which also lists 4 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 13 Jan 2026.