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Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach. Comparing leg length discrepancy, femoral offset, valgus/varus position of the stem. Also is there a difference in heterotopic ossification at 12 months.
Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468). This study is a follow-up on the same study population.
150 patients (70 to 90 years) with a displaced femoral neck fracture was randomized to be operated With either anterolateral og Direct lateral surgical approach. Investigators want to compare the radiological features of the femoral stem between the two Groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anterolateral approach | Active Comparator | Standard x-ray on all operated patients was taken pre- and postoperative and at 3 and 12 moths. Including an AP pelvis and lateral view of the hip. |
|
| Lateral approach | Active Comparator | Standard x-ray on all operated patients was taken pre- and postoperative and at 3 and 12 moths. Including an AP pelvis and lateral view of the hip. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemiarthroplasty | Procedure | Radiological features comparing the femoral stem position is measured on the postoperative x-ray. Presence of heterotopic ossification is assessed on the 12 months follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Leg length | The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head | Immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Femoral offset | The distance between the longitudinal axis of the femur to the centre of the femoral head and the distance from the centre of the femoral head to a perpendicular line passing through the medial edge of the teardrop | Immediately after surgery |
| Valgus/varus stem position |
| Measure | Description | Time Frame |
|---|---|---|
| Canal Flare index | the ratio of the intracortical width of the femur at 20 mm proximal to the tip of lesser trochanter and isthmus at 10 cm distally | Immediately after surgery |
| Dorr classification | Morphology of the proximal femur |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Nordsletten, Prof | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sorlandet Hospital | Kristiansand | 4615 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29037093 | Background | Ugland TO, Haugeberg G, Svenningsen S, Ugland SH, Berg OH, Hugo Pripp A, Nordsletten L. Less periprosthetic bone loss following the anterolateral approach to the hip compared with the direct lateral approach. Acta Orthop. 2018 Feb;89(1):23-28. doi: 10.1080/17453674.2017.1387730. Epub 2017 Oct 17. | |
| 29789919 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 5, 2022 | |
| Reset | Feb 7, 2023 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2019 | May 30, 2019 | Prot_SAP_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 5, 2022 | Feb 7, 2023 |
| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D009999 | Ossification, Heterotopic |
| D007870 | Leg Length Inequality |
| D056304 | Genu Valgum |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D062785 | Hemiarthroplasty |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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Participants attempted masked.
Stem position in relation to the femoral axis |
| Immediately after surgery |
| Heterotopic ossification | Classified as type 1-4 according to Brooker classification | 1 year |
| Canal fill ratio | Was evaluated at the following points; 2 cm above the lower trochanter, at the tip of the lower trochanter, 2 cm and 7 cm below the tip of lesser trochanter | Immediately after surgery |
| Immediately after surgery |
| Cortical Thickness Index | the ratio of cortical width minus endosteal width, to cortical width at 10 cm below the tip of lesser trochanter | Immediately after surgery |
| 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. |
| 35585787 | Derived | Tellefsen RA, Ugland T, Bjorndal MM, Ugland S, Pripp AH, Nordsletten L. Increased risk of high-grade heterotopic ossification using direct lateral approach versus a muscle-sparing anterolateral approach to the hip: radiological results from a randomised trial in patients with a femoral neck fracture treated with hemiarthroplasty. Hip Int. 2023 Jul;33(4):789-796. doi: 10.1177/11207000221097639. Epub 2022 May 18. |
| D025981 |
| Hip Injuries |
| D007869 | Leg Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |