---
title: Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study
nct_id: NCT04172129
overall_status: COMPLETED
sponsor: Smith & Nephew Orthopaedics AG
study_type: OBSERVATIONAL
primary_condition: Primary and Secondary Coxarthrosis
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04172129.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04172129"
ct_last_update_post_date: 2019-11-27
last_seen_at: "2026-05-12T06:24:26.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Assessment of Implant Fixation and SF-36 for Short Hip-Stems - A Prospective Clinical Study

**NCT ID:** [NCT04172129](https://clinicaltrials.gov/study/NCT04172129)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Smith & Nephew Orthopaedics AG
- **Conditions:** Primary and Secondary Coxarthrosis, Dysplasia Coxarthrosis, Post-traumatic Necrosis of the Femoral Head
- **Start Date:** 2011-04-26
- **Completion Date:** 2017-02-15
- **CT.gov Last Update:** 2019-11-27

## Brief Summary

The primary purpose of this study was to evaluate the implant fixation of the NANOS™ Neck Preserving Hip Stem (OHST Medizintechnik AG, distributed by Smith \& Nephew GmbH, Marl, Germany) by measuring the migration of the implant using the model-based roentgen stereophotogrammetric analysis (MBRSA).

## Eligibility

- **Minimum age:** 30 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Subject required primary total hip arthroplasty unilateral or bilateral with a diagnosis of primary and secondary coxarthrosis, dysplasia coxarthrosis and post-traumatic necrosis of the femoral head confirmed by x-ray analysis. For bilateral subjects at least three months between surgical procedures were required.
* Subject was willing to consent to participate in the study and planned to be available for the follow-up examinations.
* Subject had normal motor function of the lower extremities, documented through clinical examinations and lack of signs of a neurological disease with changed motor function.
* Subject was 30 to 65 (inclusive) years of age at time of surgery.

Exclusion Criteria:

* Subject had previous bone or soft tissue surgery of the affected hip except for arthroscopic surgery.
* Subject had a local or systemic infection.
* Subject had previously diagnosed osteoporosis.
* Subject had a femoral neck angle of \>145°.
* Subject had a femoral neck angle of \<125°.
* Subject had a disease of the cardiovascular system involving particularly reduced load capacity in the everyday life, counting as contraindication of physical stress (American Society of Anaesthesiologists' (ASA) Score 3 or 4).
* Subject had a documented allergy against elements of the implanted device.
* Subject had a neurological disease with changed motor function.
* Subject was pregnant.
* Subject had a Body Mass Index (BMI) \> 30.
* Subject suffered from alcoholism or addictive disorders.
* Subject needed a revision hip arthroplasty.
* Subject had an insufficient command of the language to understand patient information and consent.
```

## Arms

- **NANOS** — NANOS™ Neck Preserving Hip Stem

## Interventions

- **Total Hip Arthroplasty** (DEVICE)

## Primary Outcomes

- **Evaluation of migration pattern of the Nanos stem** _(time frame: 2 years)_ — Measuring migration used the model-based RSA method
- **Change in quality of life** _(time frame: 2 years)_ — Measuring change in quality of life using the Short Form (SF) 36 Mental Component Score

* Minimum Value: 0 (worst outcome)
* Maximum Value: 100 (best outcome)

## Secondary Outcomes

- **Harris Hip Score** _(time frame: 2 years)_
- **University of California, Los Angeles (UCLA) scale** _(time frame: 2 years)_
- **Pain Visual Analogue Scale** _(time frame: 2 years)_
- **Postel Merle d'Aubigné-Score** _(time frame: 2 years)_
- **Hip Disability and Ostheoarthritis Outcome Score** _(time frame: 2 years)_
- **Radiographic Evaluation** _(time frame: 2 years)_
- **Number of adverse events** _(time frame: 2 years)_

## Locations (1)

- Orthopädische Klinik der Medizinischen Hochschule Hannover, Hanover, Germany

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.orthopädische klinik der medizinischen hochschule hannover|hanover||germany` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04172129*  
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