Clinical Data

The Biodegradable Spacer as a Novel Treatment Modality for Massive Rotator
Cuff Tears: A Prospective Study with 5-year Follow-up

Vladimir Senekovic, Boris Poberaj, Ladislav Kovacic, Martin Mikek, Eliyahu Adar, Eran Maman, Assaf Dekel.

A prospective study that was conducted to assess the safety and performance of the InSpace™ in subjects having Massive Rotator Cuff Tear (RCT) and scheduled for surgical intervention. The study was conducted in Slovenia .24 subjects,  Mean age of 68.8 years, 12 male were implanted with the InSpace™ balloon.

Study outcomes:

  • No device-related adverse effects.
  • MRI (@3y PO) showedno significant findings, and no bone or cyst formation. 1 subject was suspected to have synovitis (had also a worsening of his Total Constant Score (TCS).
  • 50% of the treated subjects (12/24) had an improvement of at least 10 points in their shoulder function (TCS) 6 weeks after implantation.
  • The results indicate that the OrthoSpace InSpace™ system is a beneficial solution that can be safely and efficiently used for subjects with massive RCT that is considered irreparable.
    5 years follow up data has Published on: http://link.springer.com/article/10.1007/s00402-016-2603-9 .

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Fluoroscopy-Guided Implantation of Subacromial “Biodegradable Spacer” Using Local Anesthesia in Patients With Irreparable Rotator Cuff Tear

Enrico Gervasi, M.D., Enrico Cautero, M.D., Assaf Dekel, M.D.
Data published here.

An ongoing single center post-marketing study in Italy that is aiming to enroll up to 40 subjects that due to age or other comorbidities cannot or do not will to undergo surgical procedure under general anesthesia.

  • A fluoroscopy guided implantation technique (that was found feasible and effective in a small sub group of subjects in a previous study) is used in this study and following implantation.
  • The subjects are followed for safety and effectiveness, using Constant and ASES scores for evaluation.
  • Available data regarding 25 patients (13F, 12M) with 2Y follow up
  • Inclusion crieteria persistent pain and failure of non-operative treatment for at least 3 months
  • Mean age 73 (58-85)

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  • 16/19 (85%) Subjects who completed at least 6m follow-up has improvement in their shoulder scores of at least 15 points.
  • 3/19 (15%) had no improvement in pain nor shoulder scores
  • Summary of shoulder score of these subjects* showed the following:
    • Total Constant Score Changed from 30 to 62
    • VAS changed from 7.3 to 2.3
    • ASES changed from 22 to 68
  • All subjects who reached 12 and 24 months follow-up maintained the improvement of shoulder function

InSpace Balloon – Preliminary Results and Prospective Comparison of Results with Results of Debridement

Malte Holschen, Florian Brand, Jens D. Agneskirchner
Data published here.

Presenting a new device – the InSpaceTM Balloon for Irreparable RC tears.

Personal experience with the device, preliminary results of 24 patients totally treated:

  • 11F and 13M; mean age 62 years
  • 20 with debridement + balloon
  • 4 with partial / subtotal repair + balloon
  • Follow Up: 8 months (6-15 months); 12 were available for evaluation

A Prospective comparison of results with a series of matched in age and preop diagnosis which underwent a debridement alone –

  • 12 patients with balloon (64Y, 5F, 7M)
  • 12 patients with debridement (62Y, 7F, 5M)

Improvement in Constant Score was better in the balloon group (post op scores were similar in both groups, but Balloon patients’ preop scores were worse)

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  • Improvement of pain in most patient
  • Subjective patient evaluation encouraging
  • 2 patients revised to reverse total shoulder
  • Fibrous tissue layer subacromial / subdeltoid space (during RSA implantation)
  • Results depend on the right indication (no indication for pseudoparalytic shoulder)

Prospective Multi-Center Study of a Novel Biodegradable Inflatable Spacer to treat Massive Rotator Cuff Tears. (Short-term preliminary results).

Maman Eran, Eliyahu Adar, Dekel Assaf, Ori Safran , Shaul Beyth, Ofir Uri , Ofer Rak, Michael Berenstein, Mozes Gavriel

The study is an open-label, single-arm, multi-center prospective study. Patients with massive RCT underwent implantation with the InSpace™ spacer. Follow-up visits were scheduled according to routine clinical practice to assess safety and efficacy. Shoulder function was evaluated using the Total Constant Score (TCS).

  • 47 patients with device implantation were included (23 male, mean age 69.7 years).
  • Of these patients, 30 (46%) completed 1 year FU.
  • At the 6-month follow-up, 68.8% (22/32) of the subjects showed at least 20 points of improvement in their TCS.
  • Two device-related events (4%) occurred: One case of device displacement and one case of device removal due to deterioration in shoulder function.

CONCLUSIONS: The InSpace™ implantation in patients with massive RCT is apparently a low risk procedure, associated with low complications rate and resulting in improved shoulder function.


To the Technical article including Video @ Arthroscopy techniques by Dr Savarese

Apr 13, 2014 | Posted by | 0 comments
Disclaimer: The InSpace™ system is approved for marketing in Europe but is not approved yet for marketing in the USA. This material should be considered informational only and does not constitute an offer to sell in any jurisdiction in which this product is not yet permitted to be sold.
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