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Experimental bone putty for spinal surgery falls short in early trial

NCT ID NCT01335243

Disease control Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special bone graft material (MatriBONE mixed with the patient's own bone marrow) for spinal fusion surgery in people with painful degenerative back problems. The goal was to see how well the bones fused together after 12 months. However, the trial was stopped early, so we don't have clear results on whether it worked better than standard treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MatriBONE (a collagen scaffold with tri-calcium phosphate) combined with the patient's own bone marrow
What this could lead to
If successful, this approach could offer a safer alternative to traditional bone grafts for spinal fusion surgery.
What could go wrong
The trial was terminated early, so we don't have enough data to know if it works. It was also a small, early-phase study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

32 people

The number who actually took part.

Start date

May 2011

Finished

Jun 2015

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged between 18 and 65 years old. * Body mass index lower than 35 * Degenerative osteoarthritis painful and invalidating degenerative lumbar vertebra for at least 6 months and resistance fighter in the conservative treatment * Narrow lumbar canal and\\or spondylolisthesis with neurological disorder associated with signs of primary instability or induced to neurological liberation * Patient requiring a surgery on a single interbody level. * Given informed consent * Patient with French health system Exclusion Criteria: * For women: no efficient contraception (intra uterine device, or contraceptive pill) * Pregnant or feeding women * Surgery zone local infection local * Lumbar interbody fusion of more than two levels * Spondylolisthesis of high rank (stage 3 or 4 of the classification of Meyerding) * Scoliosis lumbar vertebra gives a complex to (Cobb angle\> 40°) * All surgical contraindications * Severe hyperparathyroidism: calcium \> 2,45 mmol/l and \[PTH\] ≥ 50pg / ml * Uncontrolled diabetes (untreated or non stabilized by treatment) * Long corticoid treatment (more than 6 months and stopped since less than 3 months) * Current Chemotherapy or during the last three months * Antecedent of regional radiotherapy * All contraindication to MatriTM BONE: osteomyelitis, bone degenerative disease or necrosis of surgery site. * Known turned out Osteoporosis untreated (dexa: \> 2 DS) * Subject participating in another research including a period of always current exclusion in the pre-inclusion * Person placed under protection of justice * Severely altered physical and\\or psychological Health, which according to, the investigator, can affect to participant's compliance to the study.

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Conditions

The condition(s) this trial relates to.

ankylosis arthropathy lumbar disk degenerative disorder lumbar disk disease lumbar spinal stenosis osteoarthritis Pain spondylolisthesis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative lumbar vertebra Degenerative osteoarthritis

Contacts and locations

Locations

  • Unité d'Orthopédie-Traumatologie rachis II, Pellegrin

    Bordeaux, 33076, France

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