FunctionNCT06760949

Comparative Study on Surgical Approaches for Elderly Femoral Neck Fractures

A study testing Direct anterior approach hemiarthroplasty and Posterior lateral approach hemiarthroplasty in people with Function and Pain, run by Fujian Provincial Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 80 years and older
Conditions the study is for: Function, Pain
What is being tested?: Direct anterior approach hemiarthroplasty and Posterior lateral approach hemiarthroplasty
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 102 participants
Where: 1 siteChina
Study dates: 1 Feb 2023to 31 May 2025
Phase: Interventional
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 80 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Fujian Provincial Hospital Trauma Center
Fuzhou, Fujian, 350001

Other trials in China

About this study

Official title: A Single Center Prospective Controlled Study of Direct Anterior Approach and Posterior Lateral Approach in the Treatment of Femoral Neck Fractures in Elderly Patients

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
Being tested: Direct anterior approach hemiarthroplasty, Posterior lateral approach hemiarthroplasty
Keywords: femoral neck fractures, direct anterior approach, hemiarthroplasty
Medical subject headings: Pain, Femoral Neck Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Direct anterior approach hemiarthroplastyProcedure or surgery
Direct anterior approach hemiarthroplasty
Posterior lateral approach hemiarthroplastyProcedure or surgery
Posterior lateral approach hemiarthroplasty

Study groups in NCT06760949
Study group	Role	What they receive
DAA group	Experimental	Patients with femoral neck fractures undergoing DAA-HA. Receives: Procedure: Direct anterior approach hemiarthroplasty
PLA group	Active comparator	Patients with femoral neck fractures undergoing PLA-HA. Receives: Procedure: Posterior lateral approach hemiarthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 1 week, 1 month, and 3 months after surgery

Secondary outcomes (10)

Operative time
Measured: Intraoperative
Intraoperative bleeding volume
Measured: Intraoperative
Intraoperative blood transfusion rate
Measured: Intraoperative
Hemoglobin value
Measured: Preoperative and postoperative 1 day
Blood creatine kinase value
Measured: Preoperative and postoperative 1 day
Incidence of complications
Measured: Perioperative period
Difference in length of both lower limbs
Measured: 3 days after surgery
Postoperative drainage volume
Measured: 24 hours after surgery
Hospital stay
Measured: The duration (in days) from admission to discharge, estimated to be no more than 21 days at most.
Mortality
Measured: 3 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202331 May 2025

First posted7 Jan 2025
Study start1 Feb 2023
Primary completion31 May 2025
Study completion31 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (28)Papers the sponsor has linked to this study.
Other trials for FunctionStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06760949
Sponsor's protocol ID: Fujian Trauma Center
Status last verified: Jun 2025
First submitted: 20 Dec 2024
Last updated: 11 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Because of unit regulations.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center Prospective Controlled Study of Direct Anterior Approach and Posterior Lateral Approach in the Treatment of Femoral Neck Fractures in Elderly Patients
ClinicalTrials.gov ID: NCT06760949
Acronym / sponsor ID: Fujian Trauma Center
Conditions: Function, Pain
Keywords: femoral neck fractures, direct anterior approach, hemiarthroplasty
Study type: Interventional
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: Fujian Provincial HospitalUniversity, hospital or other
Study start: 1 Feb 2023 (actual)
Primary completion: 31 May 2025 (actual)
Study completion: 31 May 2025 (actual)
First posted: 7 Jan 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DAA group	Experimental	Procedure: Direct anterior approach hemiarthroplastyPatients with femoral neck fractures undergoing DAA-HA.
PLA group	Active comparator	Procedure: Posterior lateral approach hemiarthroplastyPatients with femoral neck fractures undergoing PLA-HA.

Who may qualify

Ages: 80 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

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
Direct anterior approach hemiarthroplastyDirect anterior approach hemiarthroplasty	Procedure or surgery	DAA group
Posterior lateral approach hemiarthroplastyPosterior lateral approach hemiarthroplasty	Procedure or surgery	PLA group

Primary outcome

Harris hip joint function score
Time frame: 1 week, 1 month, and 3 months after surgery
Scores range from 100 to 0, with 90-100 being excellent, 80-89 being good, 70-79 being acceptable, and ≤69 being poor.
VAS pain score
Time frame: 1 week, 1 month, and 3 months after surgery
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.

10 secondary outcomes

Operative time
Time frame: Intraoperative
Intraoperative bleeding volume
Time frame: Intraoperative
Intraoperative blood transfusion rate
Time frame: Intraoperative
Hemoglobin value
Time frame: Preoperative and postoperative 1 day
Blood creatine kinase value
Time frame: Preoperative and postoperative 1 day
Incidence of complications
Time frame: Perioperative period
Difference in length of both lower limbs
Time frame: 3 days after surgery
Postoperative drainage volume
Time frame: 24 hours after surgery
Hospital stay
Time frame: The duration (in days) from admission to discharge, estimated to be no more than 21 days at most.
Mortality
Time frame: 3 months after surgery

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 11 Jun 2025.
Results publication: PubMed 33962046Dahm 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.
Results publication: PubMed 31926554Zhao 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.
Results publication: PubMed 29789919Ugland 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.
Results publication: PubMed 30262445Dimitriou 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.
Results publication: PubMed 30087014Oba 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.
Results publication: PubMed 26652329Trinh 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.
Results publication: PubMed 32255244Ding 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.
Results publication: PubMed 26254939Jiao 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.
Results publication: PubMed 28795239Jia 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.
Results publication: PubMed 30241509Saxer 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.
Results publication: PubMed 31450987Verzellotti 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.
Results publication: PubMed 22873207Renken 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.
Individual participant dataSharing planned: No. Because of unit regulations.

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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?

A study testing Direct anterior approach hemiarthroplasty and Posterior lateral approach hemiarthroplasty in people with Function and Pain, run by Fujian Provincial Hospital at 1 site in China.

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 5 inclusion and 5 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 11 Jun 2025. 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 China. 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?

Harris hip joint function score (time frame: 1 week, 1 month, and 3 months after surgery). The study lists 2 primary outcomes in all. 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 NCT06760949, which also lists 28 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 11 Jun 2025.