Retrospective Comparative Outcomes of Gamma and InterTAN Nail for Unstable Intertrochanteric Hip Fractures

NCT07282236 | Completed

• 1 other identifier: UCV/2022-2023/009
• Study Type: observational
• Target: 686
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Unstable Throchanteric Hip Fractures; Pertrochanteric Fracture of Femur

Keywords

Throchanteric Fractures; Gamma nail; InterTAN nail

Outcome Measures

Primary Outcomes (1)

• Implant-related complications

  Incidence of device-related adverse events (e.g., cut-out, varus collapse).

  6 months

Secondary Outcomes (2)

• Quality of fracture reduction

  Immediately postoperative (within 24 hours)

• Cephalic screw placement

  Immediately postoperative (within 24 hours)

Study Arms (2)

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.

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.

Device: Fracture fixation with cephalomedullary nails

Interventions

Fracture fixation with cephalomedullary nails DEVICE

No differences with the routine surgery for trochanteric fractures

Gamma Nail Group; InterTAN Nail Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Unstable trochanteric fractures confirmed radiographically according to OTA (Orthopedic Trauma Association), treated with Gamma or InterTAN nail,
• available follow-up for ≥ 6 months

You may not qualify if:

• Pathological fractures
• Polytrauma precluding standard treatment/follow-up
• Missing key variables/outcomes

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

School of Medicine and Health Sciences, Valencia Catholic University

Valencia, VALÈNCIA, 46003, Spain

Location

Related Publications (4)

• 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.

  RESULT

• 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.

  PMID: 34623474 RESULT

• Shankar 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.

  PMID: 37798062 RESULT

• Kalan 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.

  PMID: 39381356 RESULT

MeSH Terms

Interventions

Fracture Fixation

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 15, 2025
• Study Start: December 13, 2025
• Primary Completion: January 12, 2026
• Study Completion: January 12, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-10

Locations

ES (1)