Comparative Study on Surgical Approaches for Elderly Femoral Neck Fractures

NCT06760949 | Completed

• 1 other identifier: Fujian Trauma Center
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective controlled study was conducted to include patients who received hip replacement surgery for femoral neck fractures at the National Regional Trauma Center in Fujian Province from February 2023 to August 2024. Patients were randomly divided into the DAA group and the PLA group based on different surgical methods for a 3-month follow-up to compare the outcomes of the two groups. The main observation results include Harris hip joint function score (preoperative, postoperative 1 week, 1 month, 3 months), VAS pain score (preoperative, postoperative 1 week, 1 month, 3 months), and secondary observation results include surgical time, intraoperative blood loss, blood transfusion rate, difference in HB before and after surgery, difference in CK before and after surgery, perioperative complications, difference in length of both lower limbs after surgery, postoperative drainage volume, postoperative ICU occupancy rate, ICU length of stay, and total length of stay.

Conditions

Function; Pain

Keywords

femoral neck fractures; direct anterior approach; hemiarthroplasty

Outcome Measures

Primary Outcomes (2)

• Harris hip joint function score

  Scores range from 100 to 0, with 90-100 being excellent, 80-89 being good, 70-79 being acceptable, and ≤69 being poor.

  1 week, 1 month, and 3 months after surgery

• VAS pain score

  The highest score is 10 and the lowest score is 0, with the following interpretations: 0 points indicating no pain; 1-3 points indicating mild pain with little impact on daily life; 4-6 points indicating moderate pain affecting daily life and sleep; 7-9 points indicating severe pain significantly affecting quality of life; and 10 points indicating unbearable, extreme pain.

  1 week, 1 month, and 3 months after surgery

Secondary Outcomes (10)

• Operative time

  Intraoperative

• Intraoperative bleeding volume

  Intraoperative

• Intraoperative blood transfusion rate

  Intraoperative

• Hemoglobin value

  Preoperative and postoperative 1 day

• Blood creatine kinase value

  Preoperative and postoperative 1 day

Study Arms (2)

DAA group

EXPERIMENTAL

Patients with femoral neck fractures undergoing DAA-HA.

Procedure: Direct anterior approach hemiarthroplasty

PLA group

ACTIVE COMPARATOR

Patients with femoral neck fractures undergoing PLA-HA.

Procedure: Posterior lateral approach hemiarthroplasty

Interventions

Direct anterior approach hemiarthroplasty PROCEDURE

Direct anterior approach hemiarthroplasty

DAA group

Posterior lateral approach hemiarthroplasty PROCEDURE

Posterior lateral approach hemiarthroplasty

PLA group

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 80 years old;
• Diagnosed with unilateral femoral neck fracture through imaging examination;
• Patients who can tolerate surgery and agree to undergo surgery;
• Undergoing hemiarthroplasty (HA) for the first time;
• Able to walk independently and have intact cognitive function before the injury.

You may not qualify if:

• Bilateral femoral neck fractures;
• Patients with pathological fractures;
• Hip dysplasia, rheumatoid osteoarthritis, or other hip disorders;
• Patients with systemic or localized infections or inflammatory reactions at the surgical site;
• Patients with other lower limb fractures or severe injuries to other parts of the body; Patients with a history of previous hip surgery.

Sponsors & Collaborators

• Fujian Provincial Hospital: lead
• Fujian Provincial Hospital Emergency Center: collaborator

Study Sites (1)

Fujian Provincial Hospital Trauma Center

Fuzhou, Fujian, 350001, China

Location

Related Publications (28)

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  PMID: 31926554 RESULT

• Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Pripp AH, Nordsletten L. Biomarkers of muscle damage increased in anterolateral compared to direct lateral approach to the hip in hemiarthroplasty: no correlation with clinical outcome : Short-term analysis of secondary outcomes from a randomized clinical trial in patients with a displaced femoral neck fracture. Osteoporos Int. 2018 Aug;29(8):1853-1860. doi: 10.1007/s00198-018-4557-y. Epub 2018 May 22.

  PMID: 29789919 RESULT

• Dimitriou D, Helmy N, Hasler J, Flury A, Finsterwald M, Antoniadis A. The Role of Total Hip Arthroplasty Through the Direct Anterior Approach in Femoral Neck Fracture and Factors Affecting the Outcome. J Arthroplasty. 2019 Jan;34(1):82-87. doi: 10.1016/j.arth.2018.08.037. Epub 2018 Sep 3.

  PMID: 30262445 RESULT

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  PMID: 30087014 RESULT

• Trinh TQ, Ferrel JR, Pulley BR, Fowler TT. Short-term Outcomes of Femoral Neck Fractures Treated With Hemiarthroplasty Using the Anterior Approach. Orthopedics. 2015 Dec;38(12):e1091-7. doi: 10.3928/01477447-20151120-05.

  PMID: 26652329 RESULT

• Ding ZC, Zeng WN, Rong X, Liang ZM, Zhou ZK. Do patients with diabetes have an increased risk of impaired fracture healing? A systematic review and meta-analysis. ANZ J Surg. 2020 Jul;90(7-8):1259-1264. doi: 10.1111/ans.15878. Epub 2020 Apr 7.

  PMID: 32255244 RESULT

• Jiao H, Xiao E, Graves DT. Diabetes and Its Effect on Bone and Fracture Healing. Curr Osteoporos Rep. 2015 Oct;13(5):327-35. doi: 10.1007/s11914-015-0286-8.

  PMID: 26254939 RESULT

• Jia P, Bao L, Chen H, Yuan J, Liu W, Feng F, Li J, Tang H. Risk of low-energy fracture in type 2 diabetes patients: a meta-analysis of observational studies. Osteoporos Int. 2017 Nov;28(11):3113-3121. doi: 10.1007/s00198-017-4183-0. Epub 2017 Aug 9.

  PMID: 28795239 RESULT

• Saxer F, Studer P, Jakob M, Suhm N, Rosenthal R, Dell-Kuster S, Vach W, Bless N. Minimally invasive anterior muscle-sparing versus a transgluteal approach for hemiarthroplasty in femoral neck fractures-a prospective randomised controlled trial including 190 elderly patients. BMC Geriatr. 2018 Sep 21;18(1):222. doi: 10.1186/s12877-018-0898-9.

  PMID: 30241509 RESULT

• Verzellotti S, Candrian C, Molina M, Filardo G, Alberio R, Grassi FA. Direct anterior versus posterolateral approach for bipolar hip hemiarthroplasty in femoral neck fractures: a prospective randomised study. Hip Int. 2020 Nov;30(6):810-817. doi: 10.1177/1120700019872117. Epub 2019 Aug 26.

  PMID: 31450987 RESULT

• Renken F, Renken S, Paech A, Wenzl M, Unger A, Schulz AP. Early functional results after hemiarthroplasty for femoral neck fracture: a randomized comparison between a minimal invasive and a conventional approach. BMC Musculoskelet Disord. 2012 Aug 8;13:141. doi: 10.1186/1471-2474-13-141.

  PMID: 22873207 RESULT

• Carlson VR, Ong AC, Orozco FR, Lutz RW, Duque AF, Post ZD. The Direct Anterior Approach Does Not Increase Return to Function Following Hemiarthroplasty for Femoral Neck Fracture. Orthopedics. 2017 Nov 1;40(6):e1055-e1061. doi: 10.3928/01477447-20170925-08. Epub 2017 Oct 3.

  PMID: 28968478 RESULT

• Chung YY, Lee SM, Baek SN, Park TG. Direct Anterior Approach for Total Hip Arthroplasty in the Elderly with Femoral Neck Fractures: Comparison with Conventional Posterolateral Approach. Clin Orthop Surg. 2022 Mar;14(1):35-40. doi: 10.4055/cios21008. Epub 2022 Jan 21.

  PMID: 35251539 RESULT

• Bucs G, Dande A, Patczai B, Sebestyen A, Almasi R, Not LG, Wiegand N. Bipolar hemiarthroplasty for the treatment of femoral neck fractures with minimally invasive anterior approach in elderly. Injury. 2021 Mar;52 Suppl 1:S37-S43. doi: 10.1016/j.injury.2020.02.053. Epub 2020 Feb 21.

  PMID: 32115214 RESULT

• Kunkel ST, Sabatino MJ, Kang R, Jevsevar DS, Moschetti WE. A systematic review and meta-analysis of the direct anterior approach for hemiarthroplasty for femoral neck fracture. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):217-232. doi: 10.1007/s00590-017-2033-6. Epub 2017 Aug 29.

  PMID: 28852880 RESULT

• van der Sijp MPL, van Delft D, Krijnen P, Niggebrugge AHP, Schipper IB. Surgical Approaches and Hemiarthroplasty Outcomes for Femoral Neck Fractures: A Meta-Analysis. J Arthroplasty. 2018 May;33(5):1617-1627.e9. doi: 10.1016/j.arth.2017.12.029. Epub 2017 Dec 29.

  PMID: 29398259 RESULT

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  PMID: 25635363 RESULT

• Leonardsson O, Rolfson O, Rogmark C. The surgical approach for hemiarthroplasty does not influence patient-reported outcome : a national survey of 2118 patients with one-year follow-up. Bone Joint J. 2016 Apr;98-B(4):542-7. doi: 10.1302/0301-620X.98B4.36626.

  PMID: 27037438 RESULT

• Berggren M, Stenvall M, Englund U, Olofsson B, Gustafson Y. Co-morbidities, complications and causes of death among people with femoral neck fracture - a three-year follow-up study. BMC Geriatr. 2016 Jun 3;16:120. doi: 10.1186/s12877-016-0291-5.

  PMID: 27260196 RESULT

• Neyisci C, Erdem Y, Bilekli AB, Bek D. Direct Anterior Approach Versus Posterolateral Approach for Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures in Geriatric Patients. Med Sci Monit. 2020 Jan 21;26:e919993. doi: 10.12659/MSM.919993.

  PMID: 31961830 RESULT

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  PMID: 32910422 RESULT

• Huang XT, Liu DG, Jia B, Xu YX. Comparisons between Direct Anterior Approach and Lateral Approach for Primary Total Hip Arthroplasty in Postoperative Orthopaedic Complications: A Systematic Review and Meta-Analysis. Orthop Surg. 2021 Aug;13(6):1707-1720. doi: 10.1111/os.13101. Epub 2021 Aug 5.

  PMID: 34351056 RESULT

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  PMID: 15422013 RESULT

• Langlois J, Delambre J, Klouche S, Faivre B, Hardy P. Direct anterior Hueter approach is a safe and effective approach to perform a bipolar hemiarthroplasty for femoral neck fracture: outcome in 82 patients. Acta Orthop. 2015 Jun;86(3):358-62. doi: 10.3109/17453674.2014.1002987. Epub 2015 Jan 13.

  PMID: 25583401 RESULT

• Kannan A, Kancherla R, McMahon S, Hawdon G, Soral A, Malhotra R. Arthroplasty options in femoral-neck fracture: answers from the national registries. Int Orthop. 2012 Jan;36(1):1-8. doi: 10.1007/s00264-011-1354-z. Epub 2011 Sep 20.

  PMID: 21931966 RESULT

• Antapur P, Mahomed N, Gandhi R. Fractures in the elderly: when is hip replacement a necessity? Clin Interv Aging. 2011;6:1-7. doi: 10.2147/CIA.S10204. Epub 2010 Dec 20.

  PMID: 21472086 RESULT

• Sterling RS. Gender and race/ethnicity differences in hip fracture incidence, morbidity, mortality, and function. Clin Orthop Relat Res. 2011 Jul;469(7):1913-8. doi: 10.1007/s11999-010-1736-3.

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MeSH Terms

Conditions

Pain; Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 7, 2025
• Study Start: February 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)