Comparative Study on Surgical Approaches for Elderly Femoral Neck Fractures

NCT ID: NCT06760949

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2025-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DAA group

Patients with femoral neck fractures undergoing DAA-HA.

Group Type: EXPERIMENTAL

Direct anterior approach hemiarthroplasty

Intervention Type: PROCEDURE

Direct anterior approach hemiarthroplasty

PLA group

Patients with femoral neck fractures undergoing PLA-HA.

Group Type: ACTIVE_COMPARATOR

Posterior lateral approach hemiarthroplasty

Intervention Type: PROCEDURE

Posterior lateral approach hemiarthroplasty

Interventions

Direct anterior approach hemiarthroplasty

Direct anterior approach hemiarthroplasty

Intervention Type: PROCEDURE

Posterior lateral approach hemiarthroplasty

Posterior lateral approach hemiarthroplasty

Intervention Type: PROCEDURE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Provincial Hospital Emergency Center

UNKNOWN

Sponsor Role: collaborator

Fujian Provincial Hospital

OTHER

Sponsor Role: lead

Responsible Party

CHEN JIAN

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fujian Provincial Hospital Trauma Center

Fuzhou, Fujian, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 33962046 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31926554 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29789919 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30262445 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30087014 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26652329 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32255244 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26254939 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28795239 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30241509 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31450987 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22873207 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28968478 (View on PubMed)

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.

Reference Type: RESULT

PMID: 35251539 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32115214 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28852880 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29398259 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25635363 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27037438 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27260196 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31961830 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32910422 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34351056 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15422013 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25583401 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21931966 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21472086 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21161737 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Fujian Trauma Center

Identifier Type: -

Identifier Source: org_study_id