Osteoarthritis Trial, Completed NCT01066936 Sponsor: Smith & Nephew, Inc. Condition: Osteoarthritis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people who received a hip replacement implant called the MIS (Mini Stem). All participants started the study, but only 10 completed it — the other 10 did not finish, though the reasons are not detailed in the reported data. The trial was measuring bone mineral density (BMD) — that is, how dense or strong the bone is — in the thigh bone (femur) around the implant over time, using a type of scan called DEXA (Dual Energy X-Ray Absorptiometry). The thigh bone was divided into seven zones, and bone density in each zone was measured before surgery and then again at 3 months, 6 months, 1 year, and 2 years after the procedure. The reported data shows the average bone density readings (measured in grams per square centimetre) across the seven zones at each time point. Before surgery, the readings across the seven zones ranged from 0.8 to 2.0 g/cm². At 3 months after surgery, they ranged from 0.8 to 2.1 g/cm². The reported figures at 6 months, 1 year, and 2 years were broadly similar, ranging from 0.8 to approximately 2.2 g/cm² depending on the zone and time point. The outermost zone consistently recorded the lowest density reading (0.8 g/cm²) across all time points, while the middle zones recorded the highest readings. The reported data also includes a secondary measure called the Harris Hip Score, which is a tool scored from 0 to 100 that doctors use to assess how a person is functioning before or after hip surgery — a higher score means better function. Before surgery, the overall average score was reported as 49.5 out of 100, which falls in the "very poor" range on the scale. No post-surgery Harris Hip Score figures were included in the submitted results data, so those cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Osteoarthritis Trial, Completed

NCT01066936
Completed Not Applicable 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have a hip condition that means you need a total hip replacement surgery.
  • You are willing to give your consent to take part in the study.
  • You are able to stay involved for the full length of the study.
  • You are in generally stable health, and any heart, lung, blood, or other health conditions you may have are being managed and under control.

Who may not be able to join:

  • You have been found to have bones that are not strong enough to support the implant.
  • You have previously had major surgery (not including keyhole/arthroscopic surgery) on the hip being studied.
  • You have physical, emotional, or neurological (nervous system) conditions that might make it difficult to follow the recovery programme or attend follow-up appointments.
  • You have a known allergy or sensitivity to any of the materials used in the device.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Steve McMahon, MD, Malabar Orthopaedic Clinic

Australian sites

Malabar Orthopaedic Clinic, Windsor,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Smith & Nephew, Inc.
Registry
ClinicalTrials.gov
Start date
14 September 2009
Est. completion
18 April 2016

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

DEXA Analysis of BMD at Preoperative Visit; DEXA Analysis of BMD at 3 Months; DEXA Analysis of BMD at 6 Months; DEXA Analysis of BMD at 1 Year; DEXA Analysis of BMD at 2 Years

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov