CClinicalTrials.gg
CompletedNCT06760949Updated Jun 11, 2025

Comparative Study on Surgical Approaches for Elderly Femoral Neck Fractures

An interventional study of Direct anterior approach hemiarthroplasty and Posterior lateral approach hemiarthroplasty in Function and Pain, sponsored by Fujian Provincial Hospital. Completed at 1 site in China. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Fujian Provincial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Feb 2023, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
80 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Function
  • Pain

Keywords

  • femoral neck fractures
  • direct anterior approach
  • hemiarthroplasty
03

In context

Femoral Neck Fractures

204 studies on the registry are indexed under Femoral Neck Fractures; 41 are open to participants now.

This study's enrollment of 102 is close to the median of 100 across 140 interventional studies indexed under Femoral Neck Fractures.

Browse Femoral Neck Fractures studies →

Lead sponsor

Fujian Provincial Hospital is the lead sponsor of 40 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
80 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Bilateral femoral neck fractures;
  2. Patients with pathological fractures;
  3. Hip dysplasia, rheumatoid osteoarthritis, or other hip disorders;
  4. Patients with systemic or localized infections or inflammatory reactions at the surgical site;
  5. Patients with other lower limb fractures or severe injuries to other parts of the body; Patients with a history of previous hip surgery.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    DAA group

    Patients with femoral neck fractures undergoing DAA-HA.

    Procedure: Direct anterior approach hemiarthroplasty

  • Active comparator
    PLA group

    Patients with femoral neck fractures undergoing PLA-HA.

    Procedure: Posterior lateral approach hemiarthroplasty

Interventions

  • ProcedureDirect anterior approach hemiarthroplasty

    Direct anterior approach hemiarthroplasty

  • ProcedurePosterior lateral approach hemiarthroplasty

    Posterior lateral approach hemiarthroplasty

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week, 1 month, and 3 months after surgery

  2. 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.

    Time frame: 1 week, 1 month, and 3 months after surgery

Secondary outcomes

  1. Operative time

    Time frame: Intraoperative

  2. Intraoperative bleeding volume

    Time frame: Intraoperative

  3. Intraoperative blood transfusion rate

    Time frame: Intraoperative

  4. Hemoglobin value

    Time frame: Preoperative and postoperative 1 day

  5. Blood creatine kinase value

    Time frame: Preoperative and postoperative 1 day

  6. Incidence of complications

    Time frame: Perioperative period

  7. Difference in length of both lower limbs

    Time frame: 3 days after surgery

  8. Postoperative drainage volume

    Time frame: 24 hours after surgery

  9. Hospital stay

    Time frame: The duration (in days) from admission to discharge, estimated to be no more than 21 days at most.

  10. Mortality

    Time frame: 3 months after surgery

07

Study locations

1 site
  • Fujian Provincial Hospital Trauma Center
    Fuzhou, Fujian 350001, China
08

References and documents

Publications

  • Dahm F, Aichmair A, Dominkus M, Hofstaetter JG. Incidence of lateral femoral cutaneous nerve lesions after direct anterior approach primary total hip arthroplasty - a literature review. Orthop Traumatol Surg Res. 2021 Dec;107(8):102956. doi: 10.1016/j.otsr.2021.102956. Epub 2021 May 4. PubMed 33962046 ↗
  • Zhao G, Zhu R, Jiang S, Xu N, Bao H, Wang Y. Using the anterior capsule of the hip joint to protect the tensor fascia lata muscle during direct anterior total hip arthroplasty: a randomized prospective trial. BMC Musculoskelet Disord. 2020 Jan 11;21(1):21. doi: 10.1186/s12891-019-3035-9. PubMed 31926554 ↗
  • 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. PubMed 29789919 ↗
  • 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. PubMed 30262445 ↗
  • Oba T, Inaba Y, Saito I, Fujisawa T, Saito T. Risk factors for prolonged operative time in femoral neck fracture patients undergoing hemiarthroplasty through direct anterior approach. J Orthop Sci. 2018 Nov;23(6):977-981. doi: 10.1016/j.jos.2018.07.003. Epub 2018 Aug 4. PubMed 30087014 ↗
  • 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. PubMed 26652329 ↗
  • 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. PubMed 32255244 ↗
  • 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. PubMed 26254939 ↗
  • 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. PubMed 28795239 ↗
  • 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. PubMed 30241509 ↗
  • 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. PubMed 31450987 ↗
  • 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. PubMed 22873207 ↗
  • 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. PubMed 28968478 ↗
  • 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. PubMed 35251539 ↗
  • 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. PubMed 32115214 ↗
  • 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. PubMed 28852880 ↗
  • 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. PubMed 29398259 ↗
  • Florschutz AV, Langford JR, Haidukewych GJ, Koval KJ. Femoral neck fractures: current management. J Orthop Trauma. 2015 Mar;29(3):121-9. doi: 10.1097/BOT.0000000000000291. PubMed 25635363 ↗
  • 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. PubMed 27037438 ↗
  • 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. PubMed 27260196 ↗
  • 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. PubMed 31961830 ↗
  • Spina M, Luppi V, Chiappi J, Bagnis F, Balsano M. Direct anterior approach versus direct lateral approach in total hip arthroplasty and bipolar hemiarthroplasty for femoral neck fractures: a retrospective comparative study. Aging Clin Exp Res. 2021 Jun;33(6):1635-1644. doi: 10.1007/s40520-020-01696-9. Epub 2020 Sep 10. PubMed 32910422 ↗
  • 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. PubMed 34351056 ↗
  • JUDET J, JUDET R. The use of an artificial femoral head for arthroplasty of the hip joint. J Bone Joint Surg Br. 1950 May;32-B(2):166-73. doi: 10.1302/0301-620X.32B2.166. No abstract available. PubMed 15422013 ↗
  • 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. PubMed 25583401 ↗
  • 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. PubMed 21931966 ↗
  • 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. PubMed 21472086 ↗
  • 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. PubMed 21161737 ↗

Study documents

  • Protocol and statistical analysis plan · Feb 1, 2023
  • Informed consent form · Feb 1, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Because of unit regulations.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06760949
Lead sponsor
Fujian Provincial Hospital
Collaborators
Fujian Provincial Hospital Emergency Center
Responsible party
CHEN JIAN (Principal investigator, Fujian Provincial Hospital) — Principal investigator
First posted
Jan 7, 2025
Start date
Feb 1, 2023
Primary completion
May 31, 2025
Completion
May 31, 2025
Last update
Jun 11, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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